Status reporting of a structured collection procedure

ABSTRACT

Embodiments related to a system and method managing the implementation, execution, data collection, data analysis and status reporting of a structured collection procedure running on a portable, hand-held collection device are disclosed. The collection device performing the structured collection procedure has program instructions that when executed by a processor cause the processor to initiate automatically a schedule of events of the structured collection procedure upon one or more entry criteria being met at some unknown time, store in memory patient data collected in accordance to the schedule of events, end automatically the structured collection procedure upon one or more exit criteria being met at some unknown time. Status reporting can be provided throughout the execution of the collection procedure.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 12/818,894, filed Jun. 18, 2010, which is a continuation inpart of U.S. patent application Ser. No. 12/643,415, filed Dec. 21,2009, and issued as U.S. Pat. No. 9,659,037 on May 23, 2017, whichclaims priority to U.S. Provisional Application Ser. No. 61/140,270,filed Dec. 23, 2008, each of which are incorporated by reference hereinin their entirety.

TECHNICAL FIELD

Embodiments of the present invention relate generally to devicescollecting physiological information, and particularly to a system andmethod managing the implementation, execution, data collection, and dataanalysis of a structured collection procedure running on a portable,hand-held collection device as well as status reporting of thestructured collection procedure.

BACKGROUND

A disease which is long lasting or which reoccurs often is definedtypically as a chronic disease. Known chronic diseases include, amongothers, depression, compulsive obsession disorder, alcoholism, asthma,autoimmune diseases (e.g. ulcerative colitis, lupus erythematosus),osteoporosis, cancer, and diabetes mellitus. Such chronic diseasesrequire chronic care management for effective long-term treatment. Afteran initial diagnosis, one of the functions of chronic care management isthen to optimize a patient's therapy of the chronic disease.

In the example of diabetes mellitus, which is characterized byhyperglycemia resulting from inadequate insulin secretion, insulinaction, or both, it is known that diabetes manifests itself differentlyin each person because of each person's unique physiology that interactswith variable health and lifestyle factors such as diet, weight, stress,illness, sleep, exercise, and medication intake. Biomarkers are patientbiologically derived indicators of biological or pathogenic processes,pharmacologic responses, events or conditions (e.g., aging, disease orillness risk, presence or progression, etc.). For example, a biomarkercan be an objective measurement of a variable related to a disease,which may serve as an indicator or predictor of that disease. In thecase of diabetes mellitus, such biomarkers include measured values forglucose, lipids, triglycerides, and the like. A biomarker can also be aset of parameters from which to infer the presence or risk of a disease,rather than a measured value of the disease itself. When properlycollected and evaluated, biomarkers can provide useful informationrelated to a medical question about the patient, as well as be used aspart of a medical assessment, as a medical control, and/or for medicaloptimization.

For diabetes, clinicians generally treat diabetic patients according topublished therapeutic guidelines such as, for example, Joslin DiabetesCenter & Joslin Clinic, Clinical Guideline for PharmacologicalManagement of Type 2 Diabetes (2007) and Joslin Diabetes Center & JoslinClinic, Clinical Guideline for Adults with Diabetes (2008). Theguidelines may specify a desired biomarker value, e.g., a fasting bloodglucose value of less than 100 mg/dl, or the clinician can specify adesired biomarker value based on the clinician's training and experiencein treating patients with diabetes. However, such guidelines do notspecify biomarker collection procedures for parameter adjustments tosupport specific therapies used in optimizing a diabetic patient'stherapy. Subsequently, diabetic patients often must measure theirglucose levels with little structure for collection and with littleregard to lifestyle factors. Such unstructured collections of glucoselevels can result in some biomarker measurements lacking interpretativecontext, thereby reducing the value of such measurements to cliniciansand other such health care providers helping patients manage theirdisease.

A patient with a chronic disease may be asked by different clinicians atvarious times to perform a number of collections in an effort todiagnose a chronic disease or to optimize therapy. However, theserequests to perform such collections according to a schedule mayoverlap, be repeats, run counter to each other and/or provide a burdenon the patient such that the patient may avoid any further attempts todiagnose their chronic disease or to optimize therapy.

In addition, if a requesting clinician does not evaluate the patientproperly to see if the schedule of requested collections is possibleand/or whether parameters for the collections are suitable and/oracceptable for the patient, having useful results from such collectionsmay be unlikely. Still further, if there has not been enough suitabledata collected to complete the requested collections, such that the datacollected is helpful towards addressing the medical question and/or theinterests of the clinician, such a request may waste the time and effortof the clinician and the patient as well as the consumables used toperform the collections. Again, such failure may discourage the patientfrom seeking further therapy advice.

Moreover, prior art collection devices used in facilitating a scheduleof collections provide limited guidance, if any at all, and simplereminders of a collection event. Such prior art device typically need tobe programmed manually by the either clinician or the patient, in whichto govern the collection schedule. Such limited guidance andfunctionality provided by prior art collection devices can also furtherdiscourage the patient from seeking any future optimization of theirtherapy as performing another collection procedure in this manner may beviewed as being laborious by the patient, thereby leaving suchoptimization to simply guessing.

SUMMARY

It is against the above background that embodiments of the presentinvention present a system and method managing the implementation,execution, data collection, and data analysis of a prospectivestructured collection procedure running on a portable, hand-heldcollection device as well as status reporting of the structuredcollection procedure. Embodiments of the present invention can beimplemented on various collection devices, such as a blood glucosemeasuring device (meter) that has the capability to accept and runthereon one or more collection procedures and associatedmeter-executable scripts according to the present invention. Thesecollection procedures in one embodiment can be generated on a computeror any device capable of generating a collection procedure. Statusreporting of the structured collection procedure running on a device canbe in printed and/or electronic format, and be provided to both patientsand clinicians for different purposes, such as for the patient, e.g.,troubleshooting, motivation, determining health status, and the likes,and for the clinician, e.g., to learn about patients' needs, to identifydepressive patients, to determine health status, and the likes.

In one embodiment, a collection device which performs a structuredcollection procedure is disclosed. The device comprises: a display,memory, a processor connected to the memory and the display, and programinstructions. The program instructions when executed by the processorcause the processor to: initiate a schedule of events of the structuredcollection procedure upon one or more entry criteria being met, collectpatient data for the structured collection procedure when entered inresponse to a request in accordance with an event provided in theschedule of events after initiation, store automatically in the memorythe collected patient data, assess automatically whether the collectedpatient data in response to the request meets one or more adherenceand/or acceptance criteria, associate automatically with the storedcollected patient data a unique identifier in the memory if satisfyingthe one or more adherence and/or acceptance criteria, provideautomatically a status report when the one or more adherence and/oracceptance criteria are not met during the structured collectionprocedure, and end automatically the structured collection procedureupon one or more exit criteria being met.

In another embodiment, a collection device which performs a structuredcollection procedure is disclosed. The device comprises: a display;memory; a processor connected to the memory and the display; and programinstructions which when executed by the processor cause the processorto: initiate a schedule of events of the structured collection procedureupon one or more entry criteria being met, collect patient data for thestructured collection procedure when entered in response to a request inaccordance with an event provided in the schedule of events afterinitiation, store automatically in the memory the collected patientdata, assess automatically whether the collected patient data inresponse to the request meets one or more adherence and/or acceptancecriteria, associate automatically with the stored collected patient dataa unique identifier in the memory if satisfying the one or moreadherence and/or acceptance criteria, end automatically the structuredcollection procedure upon one or more exit criteria being met, andprovide automatically a status report when the one or more exit criteriais met.

In still another embodiment, a method of managing a structuredcollection procedure is disclosed and comprises providing a collectiondevice with the structured collection procedure and a programinstructions, and executing the program instruction on the collectiondevice. The program instructions cause a processor of the collectiondevice to: initiate a schedule of events of the structured collectionprocedure upon one or more entry criteria being met, collect patientdata for the structured collection procedure when entered in response toa request in accordance with an event provided in the schedule of eventsafter initiation, store automatically in the memory the collectedpatient data, assess automatically whether the collected patient data inresponse to the request meets one or more adherence and/or acceptancecriteria, associate automatically with the stored collected patient dataa unique identifier in the memory if satisfying the one or moreadherence and/or acceptance criteria, provide automatically a statusreport when the one or more adherence and/or acceptance criteria are notmet during the structured collection procedure, and end automaticallythe structured collection procedure upon one or more exit criteria beingmet.

These and other advantages and features of various embodiments of theinvention disclosed herein, will be made more apparent from thedescription, drawings and claims that follow.

BRIEF DESCRIPTION OF THE DRAWINGS

The following detailed description of the embodiments of the presentinvention can be best understood when read in conjunction with thefollowing drawings, where like structure is indicated with likereference numerals.

FIG. 1 is a diagram showing a chronic care management system for adiabetes patient and a clinician along with others having an interest inthe chronic care management of the patient according to an embodiment ofthe present invention.

FIGS. 2 and 2A are diagrams showing embodiments of a system suitable forimplementing a structured testing method according to an embodiment ofthe present invention.

FIG. 3 shows a block diagram of a collection device embodiment accordingto the present invention.

FIG. 4 shows a depiction in tabular format of a data record embodimentcreated from using a structured testing method on the collection deviceof FIG. 3 according to the present invention.

FIG. 5A depicts a method of creating a structured collection procedurefor a medical use case and/or question according to an embodiment of thepresent invention.

FIGS. 5B and 5C show parameters defining a structured collectionprocedure and factors which can be considered to optimize a patient'stherapy using the structured collection procedure, respectively,according to one or more embodiments of the present invention.

FIGS. 6A, 6B, 6C, 6D, and 6E show various structured collectionprocedures embodiments defined according to the present invention.

FIG. 7A depicts a structured testing method for diagnostic or therapysupport of a patient with a chronic disease according to an embodimentof the present invention.

FIG. 7B conceptually illustrates one example of a pre-defined structuredcollection procedure, and a method for customizing the pre-definedstructured collection procedure according to an embodiment of thepresent invention.

FIG. 8A shows a method for performing a structured collection procedureaccording to an embodiment of the present invention.

FIGS. 8B and 8C show a method of implementing a structured collectionprocedure via a graphical user interface provided on a collection deviceaccording to an embodiment of the present invention.

FIG. 9 shows a method for performing a structured collection procedureto obtain contextualized biomarker data from a patient according toanother embodiment of the present invention.

FIG. 10A depicts non-contextualized and contextualized data.

FIG. 10B depicts a typical collection procedure according to anembodiment of the present invention.

FIG. 11 depicts a diagram of accepted contextualized data intermingledwith non-acceptable contextualized data according to an embodiment ofthe present invention.

FIG. 12 depicts elements of software according to an embodiment of thepresent invention.

FIGS. 13 and 14 depict a collection procedure execution method accordingto an embodiment of the present invention.

FIG. 15 shows a method of providing diabetes diagnostics and therapysupport according to a use case embodiment of the present invention.

FIGS. 16, 17, and 18 depict different screen shots of a graphical userinterface according to an embodiment of the present invention.

FIGS. 19A-19G depict different screen shots of a graphical userinterface according to various embodiment of the present invention.

FIG. 20 shows a method for performing a structured collection procedureaccording to another embodiment of the present invention.

FIG. 21 conceptually illustrates another example of a pre-definedstructured collection procedure, and a method for customizing thepre-defined structured collection procedure according to an embodimentof the present invention.

DETAILED DESCRIPTION

The present invention will be described below relative to variousillustrative embodiments. Those skilled in the art will appreciate thatthe present invention may be implemented in a number of differentapplications and embodiments and is not specifically limited in itsapplication to the particular embodiments depicted herein. Inparticular, the present invention will be discussed below in connectionwith diabetes management via sampling blood, although those of ordinaryskill will recognize that the present invention could be modified to beused with other types of fluids or analytes besides glucose, and/oruseful in managing other chronic diseases besides diabetes.

As used herein with the various illustrated embodiments described below,the following terms include, but are not limited to, the followingmeanings.

The term “biomarker” can mean a physiological variable measured toprovide data relevant to a patient such as for example, a blood glucosevalue, an interstitial glucose value, an HbA1c value, a heart ratemeasurement, a blood pressure measurement, lipids, triglycerides,cholesterol, and the like.

The term “contextualizing” can mean documenting and interrelatingconditions that exist or will occur surrounding a collection of aspecific biomarker measurement. Preferably, data about documenting andinterrelating conditions that exist or will occur surrounding acollection of a specific biomarker are stored together with thecollected biomarker data and are linked to it. In particular, a furtherassessment of the collected biomarker data takes into account the dataabout documenting and interrelating conditions so that not only the dataas such are evaluated but also the link between data to which it iscontextualized. The data about documenting and interrelating conditionscan include for example information about the time, food and/orexercises which occurs surrounding a collection of a specific biomarkermeasurement and/or simultaneously thereto. For example, the context of astructured collection procedure according in an embodiment to thepresent invention can be documented by utilizing entry criterion forverifying a fasting state with the diabetic person before accepting abiomarker value during a Basal titration optimization (focused) testingprocedure.

The term “contextualized biomarker data” can mean the information on theinterrelated conditions in which a specific biomarker measurement wascollected combined with the measured value for the specific biomarker.In particular, the biomarker data are stored together with theinformation on the interrelated conditions under which a specificbiomarker measurement was collected and are linked thereto.

The term “criteria” can mean one or more criterions, and can be at leastone or more of a guideline(s), rule(s), characteristic(s), anddimension(s) used to judge whether one or more conditions are satisfiedor met to begin, accept, and/or end one or more procedural steps,actions, and/or values.

The term “adherence” can mean that a person following a structuredcollection procedure performs requested procedural steps appropriately.For example, the biomarker data should be measured under prescribedconditions of the structured collection procedure. If then theprescribed conditions are given for a biomarker measurement theadherence is defined as appropriate. For examples, the prescribedconditions are time related conditions and/or exemplarily can includeeating of meals, taking a fasting sample, eating a type of meal with arequested window of time, taking a fasting sample at a requested time,sleeping a minimum amount of time, and the like. The adherence can bedefined as appropriate or not appropriate for a structured collectionprocedure, a group of sample instances, or a single data point of acontextualized (biomarker) data. Preferably, the adherence can bedefined as appropriate or not appropriate by a range of a prescribedcondition(s) or by a selectively determined prescribed condition(s).Moreover the adherence can be calculated as a rate of adherencedescribing in which extent the adherence is given for a structuredcollection procedure or a single data point in particular of acontextualized biomarker data.

The term “adherence event” can mean when a person executing a structuredcollection procedure fails to perform a procedural step. For example, ifa person did not collect data when requested by the collection device,the adherence is determined as not appropriate resulting in an adherenceevent. In another example, adherence criteria could be a first criterionfor the patient to fast 6 hours and a second criterion for collecting afasting bG value at a requested time. In this example, if the patientprovides the bG sampling at the requested time but fasted only 3 hoursbefore providing the bG sample, then although the second adherencecriterion is met, the first adherence criterion is not, and hence anadherence event for the first criterion would occur.

The term “violation event” is a form of an adherence event in which theperson executing the structured collection (testing) procedure(protocol) does not administer a therapeutic at a recommended time, doesnot administer a recommended amount, or both.

The term “adherence criterion” can include adherence and can mean abasis for comparison (e.g., assessment) of a value/information relatedto a measured value and/or a calculated value with a definedvalue/information, or defined range of the values, wherein based on thecomparison, data can be accepted with approval and positive reception.Adherence criterion can be applied to contextualized biomarker data sothat a biomarker data can be accepted depending on a comparison of thecontextualized data regarding the documentation and related conditionsthat exist, or occur, during the collection of the specific biomarker.Adherence criterion can be akin to a sanity check for a given piece ofinformation, or group of information. Preferably, the adherencecriterion can be applied to a group(s) of data, or information, and canbe rejected if the adherence criterion is not fulfilled. In particular,such rejected data are then not used for further calculations thatprovide a therapy recommendation. Mainly, the rejected data can only beused to assess the adherence and/or to automatically trigger at leastone further action. For example, such a triggered action can prompt theuser to follow a structured collection procedure, or a single requestedaction, so that the adherence criterion can be fulfilled. In addition,an overall adherence criterion can be derived from averaging eachadherence criterion of a structured collection procedure or a specificsub-set of adherence criteria of the structured collection procedure toproduce an average value which can then be used to determine an overalladherence (e.g., adhered, not adhered) or a level of overall adherence(e.g., a percentage, a degree, etc.) of the person performing thestructured collection procedure to the structured collection procedure.

The adherence criterion can be also applied to a single datapoint/information so that, for instance, a biomarker datum can beaccepted depending on a comparison of the contextualized data regardingthe documentation and related conditions that exist, or occur, duringthe collection of the specific biomarker. If the adherence criterion isapplied only to a single data point, the adherence criterion can beconstrued as an “acceptance criterion”.

The term “acceptance criterion,” therefore, can include an adherencecriterion applied to a single data point but can also include furthercriteria which can be applied to a single data point. A single datapoint/information can be then accepted depending on contextualized dataand, in addition, depending on conditions and/or results of ameasurement of that specific biomarker. For example, if a measurementerror is detected, the biomarker reading can be rejected because theacceptance criterion cannot be fulfilled, e.g., due to an under-dosedetection, or other measurement errors, which can occur and can bedetected by the system. Moreover, other criteria which define a specificrange in which a measured value can be located can be defined as anacceptance criterion of a single data point/information. The acceptancecriterion can be applied to contextualized biomarker data so that asingle data point/information can be accepted depending oncontextualized data regarding the documentation and related conditionsthat exist, or occur, during the collection of the specific biomarkerand a comparison (e.g., assessment) of these data with a definedvalue/information or defined range(s) of the value for contextualizeddata.

Moreover, the acceptance criterion can include additional criteriarelated to measurement errors and/or defined ranges of measured valuesas described above. As used herein, a biomarker, or event value, can be“acceptable” if the user follows the appropriate and recommended steps(i.e., adherence), and, in a preferred embodiment, the resulting dataare within a predicted range. For example, before a sample is taken, theacceptance criteria can establish whether the steps leading up to takingof the sample were accomplished. For example, the processor in responseto a request displays the question, “Have you been fasting for the last8 hours?,” wherein a “Yes” response received by the processor via theuser interface meets the acceptance criterion for this step. In anotherexample, after the sample is taken, the processor can assess thereceived data for reasonableness using other acceptance criterion(s).For example, based on prior data, a fasting bG sample should be between120-180 mg/dl, but the received value was of 340 mg/dl, and thus failssuch acceptance criteria since it is outside the predefined range for anacceptable value. In such an example, the processor could prompt for anadditional sample. If the re-sampling fails too (i.e., not between120-180 mg/dl), the assessment provided by the processor can be that thepatient has not fasted, and, thus, the processor, as instructed by theacceptance criterion upon a failing of the re-sampling, canautomatically extend the events in the schedule of events accordingly.In this specific example, the acceptance criterion can be based on anadherence criterion for a single data point (to be fasted) as a firstacceptance criterion in combination with a predefined range of the bloodglucose value which can be expected under that condition. Only if bothcriteria are fulfilled, the acceptance criterion overall can be met.

Furthermore, the acceptance criterion for a single datapoint/information can be derived from criteria which can be generatedbased on other data points/information. For example, if the adherencecriterion of the whole collection procedure during which a single datapoint is measured or the adherence criteria of neighboring values isunder a predefined threshold, the single data point cannot be accepted.In other words, the acceptance criterion of a single data point caninclude not only the adherence criterion for the measurement of thespecific biomarker reading but also the adherence criterion of furtherbiomarker readings or of the whole collection procedure. In addition,further criteria based on neighboring or related values of the specificsingle data point/information can be determined. For example, if apattern recognition is applied to biomarker readings with similarcontextualized data as related to the single data point/information, thesingle data point/information cannot then be acceptance if a reducedreliability is presumed based on the pattern recognition. For example,if a fasting blood glucose reading is detected as too high for thespecific person under the conditions of the contextualized data incomparison to biomarker readings under similar conditions, it can beassumed that data were wrongly recorded even if, for example, anmeasurement error and/or an adherence event could not detected by thesystem itself. Consequently, the acceptance criterion can be defined bypredetermined criteria, for example, by predetermined values but can bealso defined dynamically based on data which can be generated during acollection procedure whereby specific criteria in particular values canbe derived therefrom. The acceptance criterion, therefore, can be usedto prove the reliability of a single data point/information so that onlythose values, which are significant and/or have a high reliability, canbe utilized for further calculation. As a consequence, the acceptancecriterion can ensure that a calculation of an insulin adjustmentparameter can be based only on these values which fulfill predefinedconditions that are essential for a correct insulin bolus calculationand that are accepted as values with a high reliability.

The term “data event request” can mean an inquiry for a collection ofdata at a single point in space-time defined by a special set ofcircumstances, for example, defined by time-related or not time-relatedevents.

The term “medical use case or question” can mean at least one or more ofa procedure, situation, condition, and/or question providing anuncertainty about the factuality, or existence of some medical facts,combined with a concept that is not yet verified but that if true wouldexplain certain facts or phenomena. A medical use case or question canbe pre-loaded in the system so that the diabetic person can selectbetween different medical use cases or questions. Alternatively, themedical use case or question can be defined by the diabetic personthemselves.

The terms “software” and “program” may be used interchangeably herein.

FIG. 1 shows a chronic care management system 10 for a diabetespatient(s) 12 and a clinician(s) 14 along with others 16 having aninterest in the chronic care management of the patient 12. Patient 12,having dysglycemia, may include persons with a metabolic syndrome,pre-diabetes, type 1 diabetes, type 2 diabetes, and gestationaldiabetes. The others 16 with an interest in the patient's care mayinclude family members, friends, support groups, and religiousorganizations all of which can influence the patient's conformance withtherapy. The patient 12 may have access to a patient computer 18, suchas a home computer, which can connect to a public network 50 (wired orwireless), such as the internet, cellular network, etc., and couple to adongle, docking station, or device reader 22 for communicating with anexternal portable device, such as a portable collection device 24. Anexample of a device reader is shown in the manual “Accu-Chek® Smart PixDevice Reader User's Manual” (2008) available from Roche Diagnostics.

The collection device 24 can be essentially any portable electronicdevice that can function as an acquisition mechanism for determining andstoring digitally a biomarker value(s) according to a structuredcollection procedure, and which can function to run the structuredcollection procedure and the method of the present invention. Greaterdetails regarding various illustrated embodiments of the structuredcollection procedure are provided hereafter in later sections. In apreferred embodiment, the collection device 24 can be a self-monitoringblood glucose meter 26 or a continuous glucose monitor 28. An example ofa blood glucose meter is the Accu-Chek® Active meter, and the Accu-Chek®Aviva meter described in the booklet “Accu-Chek® Aviva Blood GlucoseMeter Owner's Booklet (2007), portions of which are disclosed in U.S.Pat. No. 6,645,368 B1 entitled “Meter and method of using the meter fordetermining the concentration of a component of a fluid” assigned toRoche Diagnostics Operations, Inc., which is hereby incorporated byreference. An example of a continuous glucose monitor is shown in U.S.Pat. No. 7,389,133 “Method and device for continuous monitoring of theconcentration of an analyte” (Jun. 17, 2008) assigned to RocheDiagnostics Operations, Inc., which is hereby incorporated by reference.

In addition to the collection device 24, the patient 12 can use avariety of products to manage his or her diabetes including: test strips30 carried in a vial 32 for use in the collection device 24; software 34which can operate on the patient computer 18, the collection device 24,a handheld computing device 36, such as a laptop computer, a personaldigital assistant, and/or a mobile phone; and paper tools 38. Software34 can be pre-loaded or provided either via a computer readable medium40 or over the public network 50 and loaded for operation on the patientcomputer 18, the collection device 24, the clinician computer/officeworkstation 25, and the handheld computing device 36, if desired. Instill other embodiments, the software 34 can also be integrated into thedevice reader 22 that is coupled to the computer (e.g., computers 18 or25) for operation thereon, or accessed remotely through the publicnetwork 50, such as from a server 52.

The patient 12 can also use for certain diabetes therapies additionaltherapy devices 42 and other devices 44. Additionally, therapy devices42 can include devices such as an ambulatory infusion pump 46, aninsulin pen 48, and a lancing device 51. An example of an ambulatoryinsulin pump 46 include but not limited thereto the Accu-Chek® Spiritpump described in the manual “Accu-Chek® Spirit Insulin Pump System PumpUser Guide” (2007) available from Disetronic Medical Systems AG. Theother devices 44 can be medical devices that provide patient data suchas blood pressure, fitness devices that provide patient data such asexercise information, and elder care device that provide notification tocare givers. The other devices 44 can be configured to communicate witheach other according to standards planned by Continua® Health Alliance.

The clinicians 14 for diabetes are diverse and can include e.g., nurses,nurse practitioners, physicians, endocrinologists, and other such healthcare providers. The clinician 14 typically has access to a cliniciancomputer 25, such as a clinician office computer, which can also beprovided with the software 34. A healthcare record system 27, such asMicrosoft® HealthVault™ and Google™ Health, may also be used by thepatient 12 and the clinician 14 on computers 18, 25 to exchangeinformation via the public network 50 or via other network means (LANs,WANs, VPNs, etc.), and to store information such as collection data fromthe collection device 24 to an electronic medical record of the patiente.g., EMR 53 (FIG. 2A) which can be provided to and from computer 18, 25and/or server 52.

Most patients 12 and clinicians 14 can interact over the public network50 with each other and with others having computers/servers 52. Suchothers can include the patient's employer 54, a third party payer 56,such as an insurance company who pays some or all of the patient'shealthcare expenses, a pharmacy 58 that dispenses certain diabeticconsumable items, a hospital 60, a government agency 62, which can alsobe a payer, and companies 64 providing healthcare products and servicesfor detection, prevention, diagnosis and treatment of diseases. Thepatient 12 can also grant permissions to access the patient's electronichealth record to others, such as the employer 54, the payer 56, thepharmacy 58, the hospital 60, and the government agencies 62 via thehealthcare record system 27, which can reside on the clinician computer25 and/or one or more servers 52. Reference hereafter is also made toFIG. 2.

FIG. 2 shows a system embodiment suitable for implementing a structuredtesting method according to an embodiment of the present invention,which in another embodiment can be a part of the chronic care managementsystem 10 and communicate with such components, via conventional wiredor wireless communication means. The system 41 can include the cliniciancomputer 25 that is in communication with a server 52 as well as thecollection device 24. Communications between the clinician computer 25and the server 52 can be facilitated via a communication link to thepublic network 50, to a private network 66, or combinations thereof. Theprivate network 66 can be a local area network or a wide are network(wired or wireless) connecting to the public network 50 via a networkdevice 68 such as a (web) server, router, modem, hub, and the likes.

In one embodiment, the server 52 can be a central repository for aplurality of structured collection procedures (or protocols) 70 a, 70 b,70 c, 70 d, in which the details of a few exemplary structuredcollection procedures are provided in later sections. The server 52, aswell as the network device 68, can function also as a data aggregatorfor completed ones of the structured collection procedures 70 a, 70 b,70 c, 70 d. Accordingly, in such an embodiment, data of a completedcollection procedure(s) from a collection device of the patient 12 canthen be provided from the server 52 and/or network device 68 to theclinician computer 25 when requested in response to retrieval for suchpatient data.

In one embodiment, one or more of the plurality of structured collectionprocedures 70 a, 70 b, 70 c, 70 d on the server 52 can be provided overthe public network 50, such as through a secure web interface 55 (FIG.2A, showing another embodiment of the system 41) implemented on thepatient computer 18, the clinician computer 25, and/or the collectiondevice 24. In another embodiment, the clinician computer 25 can serve asthe interface (wired or wireless) 72 between the server 52 and thecollection device 24. In still another embodiment, the structuredcollection procedures 70 a, 70 b, 70 c, 70 d, as well as software 34,may be provided on a computer readable medium 40 and loaded directly onthe patient computer 18, the clinician computer 25, and/or thecollection device 24. In still another embodiment, the structuredcollection procedures 70 a, 70 b, 70 c, 70 d may be provided pre-loaded(embedded) in memory of the collection device 24. In still otherembodiments, new/updated/modified structured collection procedures 70 a,70 b, 70 c, 70 d may be sent between the patient computer 18, theclinician computer 25, the server 52 and/or the collection device 24 viathe public network 50, the private network 66, via a direct deviceconnection (wired or wireless) 74, or combinations thereof. Accordingly,in one embodiment the external devices e.g., computer 18 and 25, can beused to establish a communication link 72, 74 between the collectiondevice 24 and still further electronic devices such as other remotePersonal Computer (PC), and/or servers such as through the publicnetwork 50, such as the Internet and/or other communication networks(e.g., LANs, WANs, VPNs, etc.), such as private network 66.

The clinician computer 25, as a conventional personalcomputer/workstation, can include a processor 76 which executesprograms, such as software 34, and such as from memory 78 and/orcomputer readable medium 40. Memory 78 can include system memory (RAM,ROM, EEPROM, etc.), and storage memory, such as hard drives and/or flashmemory (internal or external). The clinician computer 25 can alsoinclude a display driver 80 to interface a display 82 with the processor76, input/output connections 84 for connecting user interface devices86, such as a keyboard and mouse (wired or wireless), and computerreadable drives 88 for portable memory and discs, such as computerreadable medium 40. The clinician computer 25 can further includecommunication interfaces 90 for connections to the public network 50 andother devices, such as collection device 24 (wired or wireless), and abus interface 92 for connecting the above mentioned electroniccomponents to the processor 76. Reference hereafter is now made to FIG.3.

FIG. 3 is a block diagram conceptually illustrating the portablecollection device 24 depicted in FIG. 2. In the illustrated embodiment,the collection device 24 can include one or more microprocessors, suchas processor 102, which may be a central processing unit comprising atleast one more single or multi-core and cache memory, which can beconnected to a bus 104, which may include data, memory, control and/oraddress buses. The collection device 24 can include the software 34,which provides instruction codes that cause a processor 102 of thedevice to implement the methods of the present invention that arediscussed hereafter in later sections. The collection device 24 mayinclude a display interface 106 providing graphics, text, and other datafrom the bus 104 (or from a frame buffer not shown) for display on adisplay 108. The display interface 106 may be a display driver of anintegrated graphics solution that utilizes a portion of main memory 110of the collection device 24, such as random access memory (RAM) andprocessing from the processor 102 or may be a dedicated graphicprocessing unit. In another embodiment, the display interface 106 anddisplay 108 can additionally provide a touch screen interface forproviding data to the collection device 24 in a well-known manner.

Main memory 110 in one embodiment can be random access memory (RAM), andin other embodiments may include other memory such as a ROM, PROM, EPROMor EEPROM, and combinations thereof. In one embodiment, the collectiondevice 24 can include secondary memory 112, which may include, forexample, a hard disk drive 114 and/or a computer readable medium drive116 for the computer readable medium 40, representing for example, atleast one of a floppy disk drive, a magnetic tape drive, an optical diskdrive, a flash memory connector (e.g., USB connector, Firewireconnector, PC card slot), etc. The drive 116 reads from and/or writes tothe computer readable medium 40 in a well-known manner. Computerreadable medium 40, represents a floppy disk, magnetic tape, opticaldisk (CD or DVD), flash drive, PC card, etc. which is read by andwritten to by the drive 116. As will be appreciated, the computerreadable medium 40 can have stored therein the software 34 and/orstructured collection procedures 70 a, 70 b, 70 c, and 70 d as well asdata resulting from completed collections performed according to one ormore of the collection procedures 70 a, 70 b, 70 c, and 70 d.

In alternative embodiments, secondary memory 112 may include other meansfor allowing the software 34, the collection procedures 70 a, 70 b, 70c, 70 d, other computer programs or other instructions to be loaded intothe collection device 24. Such means may include, for example, aremovable storage unit 120 and an interface connector 122. Examples ofsuch removable storage units/interfaces can include a program cartridgeand cartridge interface, a removable memory chip (e.g., ROM, PROM,EPROM, EEPROM, etc.) and associated socket, and other removable storageunits 120 (e.g. hard drives) and interface connector 122 which allowsoftware and data to be transferred from the removable storage unit 120to the collection device 24.

The collection device 24 in one embodiment can include a communicationmodule 124. The communication module 124 allows software (e.g., thesoftware 34, the collection procedures 70 a, 70 b, 70 c, and 70 d) anddata (e.g., data resulting from completed collections performedaccording to one or more of the collection procedures 70 a, 70 b, 70 c,and 70 d) to be transferred between the collection device 24 and anexternal device(s) 126. Examples of communication module 124 may includeone or more of a modem, a network interface (such as an Ethernet card),a communications port (e.g., USB, firewire, serial, parallel, etc.), aPC or PCMCIA slot and card, a wireless transceiver, and combinationsthereof. The external device(s) 126 can be the patient computer 18, theclinician computer 25, the handheld computing devices 36, such as alaptop computer, a personal digital assistance (PDA), a mobile(cellular) phone, and/or a dongle, a docking station, or device reader22. In such an embodiment, the external device 126 may provided and/orconnect to one or more of a modem, a network interface (such as anEthernet card), a communications port (e.g., USB, firewire, serial,parallel, etc.), a PCMCIA slot and card, a wireless transceiver, andcombinations thereof for providing communication over the public network50 or private network 66, such as with the clinician computer 25 orserver 52. Software and data transferred via communication module 124can be in the form of wired or wireless signals 128, which may beelectronic, electromagnetic, optical, or other signals capable of beingsent and received by communication module 124. For example, as is known,signals 128 may be sent between communication module 124 and theexternal device(s) 126 using wire or cable, fiber optics, a phone line,a cellular phone link, an RF link, an infrared link, othercommunications channels, and combinations thereof. Specific techniquesfor connecting electronic devices through wired and/or wirelessconnections (e.g. USB and Bluetooth, respectively) are well known in theart.

In another embodiment, the collection device 24 can be used with theexternal device 132, such as provided as a handheld computer or a mobilephone, to perform actions such as prompt a patient to take an action,acquire a data event, and perform calculations on information. Anexample of a collection device combined with such an external device 126provided as a hand held computer is disclosed in U.S. patent applicationSer. No. 11/424,757 filed Jun. 16, 2006 entitled “System and method forcollecting patient information from which diabetes therapy may bedetermined,” assigned to Roche Diagnostics Operations, Inc., which ishereby incorporated by reference. Another example of a handheld computeris shown in the user guide entitled “Accu-Chek® Pocket Compass Softwarewith Bolus Calculator User Guide” (2007) available from RocheDiagnostics.

In the illustrative embodiment, the collection device 24 can provide ameasurement engine 138 for reading a biosensor 140. The biosensor 140,which in one embodiment is the disposable test strip 30 (FIG. 1), isused with the collection device 24 to receive a sample such as forexample, of capillary blood, which is exposed to an enzymatic reactionand measured by electrochemistry techniques, optical techniques, or bothby the measurement engine 138 to measure and provide a biomarker value,such as for example, a blood glucose level. An example of a disposabletest strip and measurement engine is disclosed in U.S. Patent Pub. No.2005/0016844 A1 “Reagent stripe for test strip” (Jan. 27, 2005), andassigned to Roche Diagnostics Operations, Inc., which is herebyincorporated by reference. In other embodiments, the measurement engine138 and biosensor 140 can be of a type used to provide a biomarker valuefor other types of sampled fluids or analytes besides or in addition toglucose, heart rate, blood pressure measurement, and combinationsthereof. Such an alternative embodiment is useful in embodiments wherevalues from more then one biomarker type are requested by a structuredcollection procedure according to the present invention. In stillanother embodiment, the biosensor 140 may be a sensor with an indwellingcatheter(s) or being a subcutaneous tissue fluid sampling device(s),such as when the collection device 24 is implemented as a continuousglucose monitor (CGM) in communication with an infusion device, such aspump 46 (FIG. 1). In still another embodiments, the collection device 24can be a controller implementing the software 34 and communicatingbetween the infusion device (e.g., ambulatory infusion pump 46 andelectronic insulin pen 48) and the biosensor 140.

Data, comprising at least the information collected by the biosensor140, is provided by the measurement engine 138 to the processor 102which may execute a computer program stored in memory 110 to performvarious calculations and processes using the data. For example, such acomputer program is described by U.S. patent application Ser. No.12/492,667, filed Jun. 26, 2009, titled “Method, System, and ComputerProgram Product for Providing Both an Estimated True Mean Blood GlucoseValue and Estimated Glycated Hemoglobin (HbA1C) Value from StructuredSpot Measurements Of Blood Glucose,” and assigned to Roche DiagnosticsOperations, Inc., which is hereby incorporated by reference. The datafrom the measurement engine 138 and the results of the calculation andprocesses by the processor 102 using the data is herein referred to asself-monitored data. The self-monitored data may include, but notlimited thereto, the glucose values of a patient 12, the insulin dosevalues, the insulin types, and the parameter values used by processor102 to calculate future glucose values, supplemental insulin doses, andcarbohydrate supplement amounts as well as such values, doses, andamounts. Such data along with a date-time stamp 169 for each measuredglucose value and administered insulin dose value is stored in a datafile 145 of memory 110 and/or 112. An internal clock 144 of thecollection device 24 can supply the current date and time to processor102 for such use.

The collection device 24 can further provide a user interface 146, suchas buttons, keys, a trackball, touchpad, touch screen, etc. for dataentry, program control and navigation of selections, choices and data,making information requests, and the likes. In one embodiment, the userinterface 146 can comprises one or more buttons 147, 149 for entry andnavigation of the data provided in memory 110 and/or 112. In oneembodiment, the user can use one or more of buttons 147, 149 to enter(document) contextualizing information, such as data related to theeveryday lifestyle of the patient 12 and to acknowledge that prescribedtasks are completed. Such lifestyle data may relate to food intake,medication use, energy levels, exercise, sleep, general healthconditions and overall well-being sense of the patient 12 (e.g., happy,sad, rested, stressed, tired, etc.). Such lifestyle data can be recordedinto memory 110 and/or 112 of the collection device 24 as part of theself-monitored data via navigating through a selection menu displayed ondisplay 108 using buttons 147, 149 and/or via a touch screen userinterface provided by the display 108. It is to be appreciated that theuser interface 146 can also be used to display on the display 108 theself monitored data or portions thereof, such as used by the processor102 to display measured glucose levels as well as any entered data.

In one embodiment, the collection device 24 can be switched on bypressing any one of the buttons 147, 149 or any combination thereof. Inanother embodiment, in which the biosensor 140 is a test-strip, thecollection device 24 can be automatically switched on when thetest-strip is inserted into the collection device 24 for measurement bythe measurement engine 138 of a glucose level in a sample of bloodplaced on the test-strip. In one embodiment, the collection device 24can be switched off by holding down one of the buttons 147, 149 for apre-defined period of time, or in another embodiment can be shut downautomatically after a pre-defined period of non-use of the userinterface 146.

An indicator 148 can also be connected to processor 102, and which canoperate under the control of processor 102 to emit audible, tactile(vibrations), and/or visual alerts/reminders to the patient of dailytimes for bG measurements and events, such as for example, to take ameal, of possible future hypoglycemia, and the likes. A suitable powersupply 150 is also provided to power the collection device 24 as is wellknown to make the device portable.

As mentioned above previously, the collection device 24 may bepre-loaded with the software 34 or by provided therewith via thecomputer readable medium 40 as well as received via the communicationmodule 124 by signal 128 directly or indirectly though the externaldevice 132 and/or network 50. When provided in the latter matter, thesoftware 34 when received by the processor 102 of the collection device24 is stored in main memory 110 (as illustrated) and/or secondary memory112. The software 34 contains instructions, when executed by theprocessor 102, enables the processor to perform the features/functionsof the present invention as discussed herein in later sections. Inanother embodiment, the software 34 may be stored in the computerreadable medium 40 and loaded by the processor 102 into cache memory tocause the processor 102 to perform the features/functions of theinvention as described herein. In another embodiment, the software 34 isimplemented primarily in hardware logic using, for example, hardwarecomponents such as application specific integrated circuits (ASICs).Implementation of the hardware state machine to perform thefeature/functions described herein will be apparent to persons skilledin the relevant art(s). In yet another embodiment, the invention isimplemented using a combination of both hardware and software.

In an example software embodiment of the invention, the methodsdescribed hereafter can be implemented in the C++ programming language,but could be implemented in other programs such as, but not limited to,Visual Basic, C, C#, Java or other programs available to those skilledin the art. In still other embodiment, the program 34 may be implementedusing a script language or other proprietary interpretable language usedin conjunction with an interpreter. Reference hereafter is also made toFIG. 4.

FIG. 4 depicts in tabular form a data file 145 containing data records152 of self-monitored data 154 resulting from a structured collectionprocedure according to an embodiment of the present invention. The datarecords 152 (e.g., rows) along with the self-monitoring data 154 (e.g.,various one of the columns) can also provide associated therewithcontextual information 156 (e.g., other various ones of the columns aswell as via row and column header information). Such contextualinformation 156 can be collected either automatically, such as forexample via input received automatically from the measurement engine,the biosensor, and/or any one of the other devices, or via inputreceived from the user interface which was manually enter by the patientin response to a collection request (e.g., a question displayed by theprocessor 102 on the display 108) during the structured collectionprocedure. Accordingly, as such contextual information 156 can beprovided with each data record 152 in a preferred embodiment, suchinformation is readily available to a physician and no furthercollection of such information is necessarily needed to be providedagain by the patient either manually or orally after completing thestructured collection procedure. In another embodiment, if suchcontextual information 156 and/or additional contextual information iscollected after completion of a structured collection procedureaccording to the present invention, such information may be provided inthe associated data file and/or record 145, 152 at a later time such asvia one of the computers 18, 25. Such information would then beassociated with the self-monitored data in the data file 145, and thuswould not need to be provided again orally or manually. Such a processin the latter embodiment may be needed in the situation where thestructured collection procedure is implemented as or partly as a papertool 38 which is used with a collection device incapable of running thesoftware 34 implementing such a structured collection procedure.

It is to be appreciated that the date file 145 (or portions thereof,such as only the self-monitored data 154) can be sent/downloaded (wiredor wireless) from the collection device 24 via the communication module124 to another electronic device, such the external device 132 (PC, PDA,or cellular telephone), or via the network 50 to the clinician computer25. Clinicians can use diabetes software provided on the cliniciancomputer 25 to evaluate the received self-monitored data 154 as well asthe contextual information 156 of the patient 12 for therapy results. Anexample of some of the functions which may be incorporated into thediabetes software and which is configured for a personal computer is theAccu-Chek® 360 Diabetes Management System available from RocheDiagnostics that is disclosed in U.S. patent application Ser. No.11/999,968 filed Dec. 7, 2007, titled “METHOD AND SYSTEM FOR SETTINGTIME BLOCK,” and assigned to Roche Diagnostics Operations, Inc., whichis hereby incorporated by reference.

In a preferred embodiment, the collection device 24 can be provided asportable blood glucose meter, which is used by the patient 12 forrecording self-monitored data comprising insulin dosage readings andspot measured glucose levels. Examples of such bG meters as mentionedabove previously include but are not limited to, the Accu-Chek® Activemeter and the Accu-Chek® Aviva system both by Roche Diagnostics, Inc.which are compatible with the Accu-Chek® 360° Diabetes managementsoftware to download test results to a personal computer or theAccu-Chek® Pocket Compass Software for downloading and communicationwith a PDA. Accordingly, it is to be appreciated that the collectiondevice 24 can include the software and hardware necessary to process,analyze and interpret the self monitored data in accordance withpredefined flow sequences (as described below in detail) and generate anappropriate data interpretation output. In one embodiment, the resultsof the data analysis and interpretation performed upon the storedpatient data by the collection device 24 can be displayed in the form ofa report, trend-monitoring graphs, and charts to help patients managetheir physiological condition and support patient-doctor communications.In other embodiments, the bG data from the collection device 24 may beused to generated reports (hardcopy or electronic) via the externaldevice 132 and/or the patient computer 18 and/or the clinician computer25.

The collection device 24 can further provide the user and/or his or herclinician with at least one or more of the possibilities comprising: a)editing data descriptions, e.g. the title and description of a record;b) saving records at a specified location, in particular inuser-definable directories as described above; c) recalling records fordisplay; d) searching records according to different criteria (date,time, title, description etc.); e) sorting records according todifferent criteria (e.g., values of the bG level, date, time, duration,title, description, etc.); f) deleting records; g) exporting records;and/or h) performing data comparisons, modifying records, excludingrecords as is well known.

As used herein, lifestyle can be described in general as a pattern in anindividual's habits such as meals, exercise, and work schedule. Theindividual additionally may be on medications such as insulin therapy ororals that they are required to take in a periodic fashion. Influence ofsuch action on glucose is implicitly considered by the presentinvention.

It is to be appreciated that the processor 102 of the collection device24 can implement one or more structured collection procedures 70provided in memory 110 and/or 112. Each structured collection procedure70 in one embodiment can be stand-alone software, thereby providing thenecessary program instructions which when executed by the processor 102cause the processor to perform the structured collection procedure 70 aswell as other prescribed functions. In other embodiments, eachstructured collection procedure 70 can be part of the software 34, andcan be then be selectively executed by the processor 102 either viareceiving a selection from a menu list provided in the display 108 fromthe user interface 146 in one embodiment or via activation of aparticular user interface, such as a structured collection procedure runmode button (not shown) provided to the collection device 24 in anotherembodiment. It is to be appreciated that the software 34, likewise,provides the necessary program instructions which when executed by theprocessor 102 cause the processor to perform the structured collectionprocedure 70 as well as other prescribed functions of the software 34discussed herein. One suitable example of having a selectable structuredcollection procedure provided as a selectable mode of a collection meteris disclosed by in U.S. patent application Ser. No. 12/491,523, filedJun. 25, 2009, titled “Episodic Blood Glucose Monitoring System With AnInteractive Graphical User Interface And Methods Thereof,” assigned toRoche Diagnostics Operations, Inc., which is hereby incorporated byreference.

In still another embodiment, a command instruction can be sent from theclinician computer 25 and received by the processor 102 via thecommunication module 124, which places the collection device 24 in acollection mode which runs automatically the structured collectionprocedure 70. Such a command instruction may specify which of the one ormore structured collection procedures to run and/or provide a structuredcollection procedure to run. In still another embodiment, a list ofdefined medical use cases or medical questions can be presented on thedisplay 108 by the processor 102, and a particular structured collectionprocedure 70 can be automatically chosen by the processor 102 from aplurality of structured collection procedures (e.g., procedures 70 a, 70b, 70 c, and 70 d) depending on the selection of the defined medical usecases or medical questions received by the processor 102 via the userinterface 146.

In still another embodiment, after selection, the structured collectionprocedure(s) 70 can be provided through the computer readable mediume.g., 40 and loaded by the collection device 24, downloaded fromcomputer 18 or 25, the other device(s) 132, or server 52. Server 52, forexample, may be a healthcare provider or company providing suchpre-defined structured collection procedures 70 for downloadingaccording to a selected defined medical use case or question. It is tobe appreciated that the structured collection procedure(s) 70 may bedeveloped by a healthcare company (e.g. company 64) and implemented viathe public network 50 through a webpage and/or made available fordownloading on server 52, such as illustrated in FIG. 2. In still otherembodiments, notices that a new structured collection procedure 70 isavailable for use on the collection device 24 to help address aparticular use case/medical question that a user (e.g., healthcareprovider and patient) may have can be provided in any standard fashion,such for via postal letters/cards, email, text messaging, tweets, andthe likes.

In some embodiments, as mentioned above previously, a paper tool 38 canperform some of the functions provided by the diabetes software 34. Anexample of some of the functions which may be incorporated into thediabetes software 34 and which is configured as a paper tool 38 is theAccu-Chek® 360 View Blood Glucose Analysis System paper form availablefrom Roche Diagnostics also disclosed in U.S. patent application Ser.No. 12/040,458 filed Feb. 29, 2007 entitled “Device and method forassessing blood glucose control,” assigned to Roche DiagnosticOperations, Inc., which is hereby incorporated by reference.

In still another embodiment, the software 34 can be implemented on thecontinuous glucose monitor 28 (FIG. 1). In this manner, the continuousglucose monitor 28 can be used to obtain time-resolved data. Suchtime-resolved data can be useful to identify fluctuations and trendsthat would otherwise go unnoticed with spot monitoring of blood glucoselevels and standard HbA1c tests. Such as, for example, low overnightglucose levels, high blood glucose levels between meals, and earlymorning spikes in blood glucose levels as well as how diet and physicalactivity affect blood glucose along with the effect of therapy changes.

In addition to collection device 24 and software 34, clinicians 14 canprescribe other diabetes therapy devices for patients 12 such as anambulatory insulin pump 46 as well as electronically based insulin pen48 (FIG. 1). The insulin pump 46 typically includes configurationsoftware such as that disclosed in the manual “Accu-Chek® Insulin PumpConfiguration Software” also available from Disetronic Medical SystemsAG. The insulin pump 46 can record and provide insulin dosage and otherinformation, as well as the electronically based insulin pen 48, to acomputer, and thus can be used as another means for providing biomarkerdata as requested by the structured collection procedure 70 (FIG. 2)according to the present invention.

It is to be appreciated that, and as mentioned above previously, one ormore of the method steps discussed hereafter can be configured as apaper tool 38 (FIG. 1), but preferably all the method steps arefacilitated electronically on system 41 (FIG. 2) or on any electronicdevice/computer, such as collection device 24, having a processor andmemory as a program(s) residing in memory. As is known, when a computerexecutes the program, instructions codes of the program cause theprocessor of the computer to perform the method steps associatedtherewith. In still other embodiments, some or all of the method stepsdiscussed hereafter can be configured on computer readable medium 40storing instruction codes of a program that, when executed by acomputer, cause the processor of the computer to perform the methodsteps associated therewith. These method steps are now discussed ingreater detail hereafter with reference made to FIGS. 5A and 5B.

Create a Structured Collection Procedure

FIG. 5A depicts a method 200 of creating a structured collectionprocedure 70 illustrated by FIG. 5B for a medical use case or questionwhich may be implemented in any one of the above described devices 18,24, 25, 26, 28, 36, 52 as stand alone software, as part of the diabetessoftware 34 or portions there of as part of paper tool 38. In step 202,a medical use case or question, hereafter referred to generally as usecase(s), is selected and/or can be defined. It is to be appreciated thata use case may be, for example, one selected from the following medicaluse cases or questions: a desire to know the effects of eating aparticular food; a desire to know the best time to take medicationbefore and/or after with a meal; and a desire to know the effects ofexercise on bG levels. Other use cases may be questions concerningfinding a diagnosis, how best to initialize therapy for a patient,finding a determination of status of a patient disease progression,finding the best ways to optimize a patient therapy, and the like. Stillother examples can be providing such structured collection procedures 70which can be used to help address medical questions regarding fastingblood glucose, pre-prandial glucose values, postprandial glucose values,and the like. Other medical questions can be to control the biomarker ina predefined context, to optimize the biomarker in a predefined context,related to therapy onset, type of therapy, oral mono-therapy, oralcombination therapy, insulin therapy, lifestyle therapy, adherence totherapy, therapy efficacy, insulin injection or inhalation, type ofinsulin, split of insulin in basal and bolus, and the likes. Forexample, medical questions regarding oral mono-therapy and oralcombination could include those involving sulfonylureas, biguanides,thiazolidinediones, alpha-glucosidase inhibitors, meglitinides,dipeptidyl peptidase IV inhibitors, GLP-1 analogs, taspoglutide, PPARdual alpha/gamma agonists, aleglitazar. The selected use case can beassigned to a medical use case parameter 220 depicted in FIG. 5B.

In step 204, the situation or problem surrounding the selected use casecan be defined. This can be accomplished via looking at all the factorswhich may affect a change in the use case. For example, in the use caseof desiring to know how best to optimize a patient's therapy somefactors to look at may include stress, menstrual cycle, pre-dawn effect,background insulin, exercise, bolus timing with respect to a meal, basalrate, insulin sensitivity, post-prandial behavior, and the like such asshown by FIG. 5C.

In step 206, a determination can be made as to what kinds of analysiscan be used to address or shed light on the situation or the problem.Such analysis may be, for example, selected from the following:evaluating the change in fasting blood glucose (FPG) values over thecourse of the collection procedure 701, monitoring one or moreparticular value over the duration of the collection procedure 70,determining an insulin to carbohydrate (I:C) ratio, determining insulinsensitivity, determining best time for administering a drug with respectto another variable, such as meal(s), and the like. In step 208, asampling group determination can be made as to which information has tobe collected, such as what biomarker(s) and the context(s) in which thebiomarkers shall be collected, as well as when this information needs tobe collected to conduct the analysis. For example, the sampling groupcan be defined as a string of data objects, each of which consists of:target type, e.g., time based which can use a target time (e.g., usedfor an alerting feature), a lower time window bound, an upper timewindow bound, etc., or data based which defines a data type (single,aggregate, or formula), the conditions for accepting the data (e.g.,none, below a value, above a value, a formula, etc.), the type ofcollection (e.g., user input, sensor, data, etc.), as well as anyreminder screen text (e.g., static, and/or dynamic in both formattingand value insertion) for each collection. The result of this process isa schedule of collection events 222 (FIG. 5B). Next in step 210, themanner in which each or a group of the schedule of collection events 222is/are to be conducted in order to be useful for addressing thesituation or problem of the selected use case is then determined. Thisresults in one or more adherence criteria 224. In addition to and/orinstead of the manner for performing a collection, the adherencecriteria 224 may also be based on one or more biomarker values fallinginto a pre-defined range or is equal to a certain pre-defined value. Inother embodiments, the adherence criteria can be a formula(s) which usesa biomarker datum or group of such data to determine if the resultingvalue falls into the pre-defined range or is equal to a certainpre-defined value.

For example, adherence criteria 224 can describe the parameters aroundthe events 237 that the patient 12 needs to perform such as tests withina certain window, fasting for a given amount of time, sleeping for agiven amount of time, exercise, low stress, not menstruating, etc. Assuch, an adherence criteria 224 can establish the context of theinformation about to be provided. Adherence criteria 224 can also beused as mentioned above previously in another context to provide anassessment of whether the data is acceptable, and when used in such acontext may be referenced to as “acceptance” criteria. For example,before a sample is taken, the adherence criteria 224 can establishwhether steps leading up to taking of the sample are accomplished. Forexample, the processor 102 in response to a request 240 displays thequestion, “Have you been fasting for the last 8 hours?”, wherein a “Yes”response received by the processor via the user interface 146 meets theadherence criteria 224 for this step. In another example, after thesample is taken, the processor 102 can assess the received data forreasonableness using other adherence (acceptance) criteria. For example,based on prior data, a fasting bG sample should be between 120-180mg/dl, but the received value was of 340 mg/dl, and thus fails suchadherence (acceptance) criteria since being out of the predefined rangefor an acceptable value. In such an example, an adherence event 242occurs wherein the processor 102 could prompt for an additional sample.In such a case, if the re-sampling fails too (i.e., not between 120-180mg/dl), the assessment provided by the processor 102 is that the patient12 has not fasted, and thus the processor 102 as instructed by theadherence criteria upon a failing of the re-sampling extendautomatically the events 237 in the schedule of events 222 accordingly.

Next in step 212, the condition(s) and context(s) in which the scheduleof events 222 is to be started and ended can be determined. This resultsin one or more entry criteria 226 and exit criteria 228 being providedfor the schedule of events 222 as well as possibly for a group of otherschedule of events to which the schedule of events 222 belongs ifproviding a package of structured collection procedures, e.g.,procedures 70 a, 70 b, 70 c, and 70 d, which may run concurrently and/orsequentially one after the other.

For example, the one or more entry criteria 226 can be used to determinewhether the patient meets the conditions to use the collection procedureby the processor 102 checking that, for example, the patient 12 meetsthe entry criteria 226 based on current age being in a range, HbA1cbeing in a range, that the patient has a particular disease, has had thedisease over a minimum period of time, has a Body Mass Index (BMI) in arange, had a Fasting Plasma Glucose (FPG) in a range, had a particulardrug sensitivity, is taking a particular drug, taking a particular drugdosage, meets one or more prerequisites of another structured collectionprocedure, has completed one or more of another structured collectionprocedure, does not have one or more particular pre-conditions, e.g.,pregnant, not fasting, or contraindications, e.g., feeling ill,feverish, vomiting, etc., and combinations thereof. Entry criteria 226can also initiate the schedule of events 222 by an initiation event suchas a time of day, a time of week, meal, taking a meal with a timeoffset, exercise, and exercise with a time offset, use of a therapeuticdrug, use of a therapeutic drug with time offset, physiologicalcircumstances, biomarker range, and biomarker within a predeterminedrange calculated as an offset from a prior biomarker value. Example of aphysiological circumstance can be that entry criteria will be met tostart a structured collection procedure when a pre-determined number ofa physiological event, e.g., hyperglycemia, hypoglycemia, a certaintemperature at a certain of day, and the like, occur within apre-defined amount of time, e.g., hours, day, weeks, etc. Accordingly,the entry criteria can be used to support the use of need to metprerequisites, indications for usage, and/or contraindications forusage. For example, an entry criteria 226 could define a prerequisitecondition which in order for the structured collection procedure 70 torun an Insulin Sensitivity optimization, the processor 102 must verifyfirst that a structured collection procedure for a Basal titration iscompleted and/or has a desired result and/or as well as anotherstructured collection procedure for an insulin to carbohydrate ratio iscompleted and/or has a desired result. In another example, an entrycriteria 226 could be defined with needing to meet certain indicationsfor usage in which certain structured collection procedures couldprovide segregated uses for diabetics who are Type 1 vs. Type 2 as wellas types of structured collection procedures which can be used totitrate for specific drugs. In another example, the entry criteria 226could be defined with needing to meet certain contraindications forusage, in which for example, certain structured collection procedures 70will not run if the patient 12 is pregnant, sick, etc.

Examples of the one or more exit criteria 228 can be based on theprocessor 102 determining that a particular value is reached, that amean average of the samples values are in a range, that a particularevent(s) and/or condition(s) have or have not occurred, and combinationsthereof. Other conditions when the procedure may stop can includeadverse events such as a hypoglycemic event, the patient is sick, thepatient undergoes a therapy change, etc. Additional detail may also byprovided by the processor 102 on the display 108 to the patient 12 basedon what the specific exit criteria has been met. For example, in oneexample, if the patient 12 measures a glucose value indicatinghypoglycemia, upon exiting the procedure, the processor 102 runautomatically another alternative procedure which instructs the patient12 to ingest carbohydrates and measure his blood glucose value everyhalf an hour until the blood glucose exceeds 120 mg/dL. For thisalternative procedure, the patient 12 can also be requested by theprocessor 102 to document his meals, activity, stress, and otherrelevant details to ensure that the conditions that led to hypoglycemiaare recorded. The patient 12 may also be instructed by the processor 102to contact the clinician 14 in this and other such special cases asdeemed fit. Exit criteria can also include, for example, criteria forending such as exiting after a successful completion, or exiting afteran indeterminate completion, such as expiration of a predeterminedtimeout (logistical end), e.g., no result after n days, where n=1 to 365days, or by termination e.g., exit with unsuccessful termination due toa fail-safe. It is to be appreciated that the structured collectionprocedure 70 can also be defined to end automatically not only based onmeeting the exit criteria 228, but also when the patient 12 fails toperform a request to an acceptable level of compliance and/or when apatient physiological state has changed such that the patient is shouldnot carry out the schedule of events 222, thereby failing adherencecriteria 224, wherein the adherence event 242 is to end the structuredcollection procedure.

In step 214, guidance 230 for the user during collection can bedetermined as well as any options 232 for customizing the collection.For example, for guidance 230, the clinician 14 can use a default listof messages, or tailor messages to guide the patient 12 during executionof the collection procedure 70. As an example, one message could beprovided on a successful data acquisition (i.e., meets the adherencecriteria 224) would read, “Thank you. Your next scheduled measurement isat 12:30 pm.” Alarms, such as provided by indicator 148, can also beassociated with the collection procedure 70 that remind the patient 12to take a measurement and can include a snooze functionality should thepatient 12 need additional time to conduct the measurement. The snoozefunctionality as well as other device features are discussed further inlater sections.

The result of steps 208-214 is the structured collection procedure 70being created in step 216 which associates together the use caseparameter 220, the scheduled of events 222, the adherence criteria 224,the entry criteria 226, the exit criteria 228, guidance 230, and theoptions 232. In one embodiment, at the time of generating a collectionprocedure 70 the clinician 14 also generates printed material thatexplains to the patient the following aspects (at a minimum): thepurpose of the collection procedure 70 and expected ideal outcome, i.e.,setting a goal for the collection procedure 70; the collection procedure70 design and the number of measurements needed; the entry criteria 226that the patient 12 must satisfy before initiating the collectionprocedure 70 and before taking each reading; and the exit criteria 228under which the patient 12 should cease to continue the collectionprocedure 70. Such printed material as well as the guidance 230 that canbe provided during the execution of the collection procedure 70 ensuresthat the patient is fully aware of why the data collection procedure isbeing carried out.

Examples, of the structured collection procedure 70 may be, for example,a structured collection procedure for determining aninsulin-to-carbohydrate ratio, for determining bolus timing in respectto meal start, and for determining an exercise equivalent to ingestedcarbohydrates. In step 218, the structured collection procedure 70 isthen made available for implementation and use in the system 41, such asin any of the above discussed manners mentioned with regards to FIGS. 1,2, and 3. A structured collection procedure 70 accordingly may beprovided via the above process, such as by either the medical communityor healthcare companies 64, to help the clinician 14 address and/orinvestigate a defined medical use case or problem.

FIG. 5B shows the interactions of the parameters 222, 224, 226, and 228of the structured collection procedure 70 for obtaining contextualizedbiomarker data from a diabetic patient to address a medical use caseupon which the structured collection procedure is based. As mentionedabove, the use case parameter 220 may be provided to identify themedical use case or question to which the parameters 222, 224, 226, and228 address. For example, the processor 76 of the clinician computer 25,the processor 102 of the collection device 24, and/or the server 52 mayread the medical use case parameters 220 from a plurality of structuredcollection procedures 70 a, 70 b, 70 c, 70 d (FIG. 2), such as providedon these devices and/or within the system 41, and provide a list of theavailable structured collection procedures, such as on the display 82 ofthe clinician computer 25 or the display 108 of the collection device24. Additionally, the clinician computer 25, the patient computer 18,and/or the server 52 can use the medical use case parameter 220 forlocating/sorting/filtering such structured collection proceduresaccording to a medical use case(s).

As mentioned above, the entry criteria 226 establishes the requirementsfor initiating the structured collection procedure 70 to obtain patientdata which includes biomarker data, particularly, collected in apredefined context. In one embodiment, the processor 102 of thecollection device 24 can use the entry criteria 226 to determine when anassociated structured collection procedure 70 is appropriate for thepatient's physiological context and to ensure that all of the necessaryinputs to the associated structured collection procedure have beenestablished. Therefore, it is to be appreciated that the start dateand/time of a structured collection procedure may dynamically changeautomatically by the processor 102 of the collection device 24 if thepredefined condition(s) of the entry criteria 226 is not satisfied.Accordingly, until the entry criteria 226 is satisfied, the start dateand/time of the associated structured collection procedure 70 can be atsome unknown time in the future.

For example, in one embodiment, a structured collection procedure 70 canbe chosen automatically by the processor 102 from a plurality ofstructured collection procedures 70 a, 70 b, 70 c, 70 d, such asprovided in memory 110 of the collection device 24, memory of thecomputer 18, 25 and/or from server 52, based on satisfying thecondition(s) of a defined entry criteria 226 for an associatedstructured collection procedure. For example, in one embodiment, a firststructured collection procedure, such as procedure 70 d, is useful forshowing trends in blood glucose levels (“bG Level Trending”). Therefore,an entry criteria 226 for the first structured collection procedure 70 dmay be for the patient to have a bG level mean which has elevated over adefined period (e.g., a past number of days, weeks, and months from thecurrent date) above a certain pre-defined rate. For a second structuredcollection procedure, such as procedure 70 a, its entry criteria 226 mayrequire a particular number of bG measurement for a pre-breakfastmeasurement over a defined period (e.g., a past number of days, weeks,months, from the current date) being below a pre-defined bG value. Insuch an example, the processor 102 upon start up in one embodiment whencommanded, such as via input received via the user interface, in anotherembodiment, or at a scheduled time as programmed by the software 34 inanother embodiment, can run through the various entry criteria 226provided by the various structured collection procedures 70 a and 70 dthat are, for example, provided in memory 110 of the collection device24 and determine whether the stated condition(s) for the entry criteria226 of a particular procedure 70 is satisfied. In this example, theprocessor 102 determines that the historical data from past measurementsin memory 110 indicate that the patient's bG level mean has beenelevating, and that the entry criteria 226 for the first collectionprocedure 70 d has been met, but not the entry criteria for the secondcollection procedure 70 a. In this example, the processor 102 thenautomatically selects and starts the first structured collectionprocedure 70 d based on the above-mentioned analysis.

It is also to be appreciated that the use of the entry criteria 226 canhelp to reduce the misallocation of medical expenses by assuring thatthe indications of use for the structured collection procedure 70 havebeen met before starting the schedule of collection events 222. Theentry criteria 226 as well can help assure that any requests to performmultiple structured collection procedures do not overlap ifincompatible, are not unnecessary repeats of each other, or provide asignificant burden on the patient. In this manner, many of the notedproblems in which a patient may avoid any further attempts to diagnosetheir chronic disease or to optimize therapy can be both addressed andavoided automatically by the processor 102 of the collection device 24via use of the entry criteria 226.

As shown by FIG. 5B, the entry criteria 226 can include context specificentry criteria 234, procedure specific entry criteria 236, andcombination thereof. Examples of context specific entry criteria 234 caninclude one or more variables to identify meals, low blood glucoseevents, insulin type and dosage, stress, and the like. In anotherexample, the context specific entry criteria 234 can be defined such asin the form of a specific question(s), to which the processor 102requires a specific answer to be received from patient via input fromthe user interface 146. For example, the processor 102 in executing theentry criteria 226 may display on the display 108 the question ofwhether the patient is willing and able to perform the structuredcollection procedure 70 over the required period. If the patientresponses affirmatively via the user interface 146, then the entrycriteria 226 has been satisfied and the processor 102 continuesautomatically with performing the collection events 237 according to thetheir associated timing as defined in the structured collectionprocedure 70. If the patient responses in the negative to the displayedquestion, then the processor 102 will not continue with the structuredcollection procedure 70, and may for example, re-schedule the asking ofsuch a question to a future time, such as if designated by an optionsparameter.

Examples of procedure specific entry criteria 236 can include one ormore variables to identify disease state, disease status, selectedtherapy, parameter prerequisites, insulin to carbohydrate ratio prior totesting insulin sensitivity, incompatible collection procedures, and thelike. The procedure specific entry criteria 236 can be defined such thatthe processor 102 will continue automatically with the structuredcollection procedure 70 with one of three initiators—the patient 12, theclinician 14, or data, e.g., if the condition(s) of the entry criteria226 is satisfied. For example, the procedure specific entry criteria 236can be satisfy if the clinician 14 has prescribed the structuredcollection procedure 70, such as via an authorized user entering via theuser interface 146 a valid password to unlock the particular structuredcollection procedure for use, in one embodiment. In another embodiment,the clinician 14 can send the password or an authorization code fromclinician computer 25 and/or server 52 to the collection device 24 whichprescribes (authorizes) the collection procedure 70 for use by thepatient 12 on the collection device 24. It is to be appreciated that oneor more structured collection procedure 70 can be provided in memory 110of the collection device 24 which cannot be used by the patient 12, andwhich can be also hidden from being viewed on the display 108, such asin a selection list, by the patient until authorized by the clinician14.

The procedure specific entry criteria 236 can be satisfy by a user forexample, by the user selecting a particular structured collectionprocedure 70 from a listing of structured collection procedures 70 a, 70b, 70 c, 70 d provided on the display 108. An example of a datainitiated procedure for criteria 236 would be that a biomarkermeasurement(s) provided to the processor 102 indicates a certaincondition which must have occurred or be present in order for the entrycriteria 226 for the particular structured collection procedure to besatisfied. Such a condition, for example, can be the occurrence of asingle event, such as a severe hypoglycemic event, or a series ofevents, such as hypoglycemic events within a given, a predetermined timeframe, such as in 24 hours from a start time, in one week from a starttime, etc, a calendar date-time, and the like.

Accordingly, the entry criteria 226 can be a single criterion ormultiple criteria that establish context and/or condition of thepatient's physiology that are relevant to the medical use case beingaddressed by the structured collection procedure 70. In anotherembodiment, the entry criteria 226 can be assessed after patient datahas been collected, such as, on historical patient data.

The schedule of events 222 specifies one or more events 237 which eachcomprises at least one or more variables defining a performance time238, the guidance 230 to perform the event, requests 240 for patientactions, which may include a request for information from the patientand/or a request for collection of at least one type of biomarker datafrom the patient, and combinations thereof. For performance time 238,the schedule of events 222 can specify timing of each event 237, such asfor a biomarker sampling at a particular time on three consecutive workdays, or one sample at time of wake-up, one sample thirty minutes later,and another sample one hour later.

The guidance 230 for each event 237 and for any criteria 224, 226, 228may include, for example, providing electronic reminders (acoustic,visual) to start, end and/or wake up at a particular time, to perform abG collection at a particular time, to ingest a particular meal orfood(s) at a particular time, to perform a certain exercise(s) at aparticular time, take medication at a particular time, and the like.Guidance 230 may also include information, questions and requests torecord particular information about physiology, health, sense ofwell-being, etc., at a particular time, suggestion to improve compliancywith the collection procedure, encouragement, and positive/negativefeedback.

It is to be appreciated that the events 237 define all the steps thatare necessary to be preformed in advance of as well as after a biomarkersampling according to a request 240, such that a reproducible set ofcircumstances, i.e., context before and/or after the sampling, iscreated in the biomarker data for the biomarker sampling. Examples ofsuch biomarker data, in the context of diabetes, include fasting bloodglucose values, pre-prandial glucose values, postprandial glucosevalues, and the like. Examples of a set of circumstances can includedata associated with the biomarker value which identifies collectedinformation in the patient data about meals, exercises, therapeuticadministration, sleep, hydration, and the likes.

Each of the events 237 in the schedule of events 222 can be time-based,event-based, or both. An event 237 can also be a start of a meal, awake-up time, start of exercise, a therapeutic administration time, arelative offset used with a prior glucose value, or a time indicatingmovement above or below a predetermined biomarker value threshold. Theevents 237 can also include any required patient actions necessary to beperformed in advance of and during biomarker sampling such thatreproducible circumstances are created at the time of biomarkersampling. This can includes one or more of meals, exercise, therapeuticadministration, sleep, hydration, and the like. Additionally, the events237 in the schedule of events 222 can be adjusted (number, types,timing, etc.), to accommodate work schedule, stressors, and the like ofthe patient 12.

As mentioned above previously, the adherence criteria 224 is used toassess qualitatively whether an event 237 performed according to theschedule of events 222 provided data which is acceptable to addressingthe medical use case upon which the structured collection procedure 70is based. In particularly, the adherence criteria 224 can providevariables and/or values used to validate data from a performed event237. For example, an adherence criteria 224 can be a check performed bythe processor 102 of the collection device 24 that a value collected inresponse to an event 237 is within a desired range, or is above, below,or at a desired value, wherein the value may be a time, a quantity, atype, and the like. The same or different adherence criteria 224 may beassociated with each of the events 237 within the schedule of events 222as well with the entry criteria 226 in one embodiment, and as being theexit criteria 228 in another embodiment, such as illustrated by FIG. 6D(i.e., “stop exercising when bG back in target range” which defines boththe adherence and exit criteria). In one embodiment, one or more events237 in the schedule of events 222 may be modified (e.g., added, deleted,delayed, etc.) if a particular event or events fail to met the adherencecriteria 224 for the particular event or events. In one embodiment, thefailure of the adherence criteria 224 can trigger an adherence event242. In one embodiment, upon occurrence of an adherence event 242 due tothe associated adherence criteria 224 for an event 237 not being met orsatisfied, the processor 102 may be required one or more additionalactions as a consequence. For example, the processor 102 may prompt onthe display 108 additional information to the patient, and/or prompt aquestion to determine whether the patient 12 is sick, stressed, orunable to perform the request e.g., eat the meal, or exercise. If thepatient answers “Yes”, e.g., via the user interface 146, then as part ofthe adherence event 242 the processor 102 can provide a delay to theschedule of event (i.e. suspend). In one embodiment, the delay cancontinue until the patient indicated that he or she is better inresponse to another question prompter by the processor 102, such as thenext day or after a predefined amount of time as also part of theadherence event. For example, the patient 12 is prompted by theprocessor 102 to administer a drug, but the patient is not at home, suchas for example, where his/her insulin is located. The patient 12 canselect the delay via the user interface 146, wherein the processor 102re-prompts the patient after a predetermined amount of time. This delaymay also have an upper limit in which if the schedule of events is notre-started within a certain amount of the time, the structuredcollection procedure 70 in such a circumstance may just end. In anotherembodiment, another form of an adherence event is a violation event,which results when the person executing a structured collectionprocedure 70 fails to make a recommended change in response to arequest. For example, the request may be for the patient to adjust adrug dosage from 10U to 12U, wherein the patient answers in the negativeto a question on the displayed on the display 108 asking if the patientwill or has complied with such a change. In response to such a violationevent, the processor 102 may also send a message and/or provide a delayas previously discussed above concerning the adherence event.

In another example and in one embodiment, a bG measurement must becollected before each meal in order for a structured collectionprocedure 70 to provide data that is useful in addressing the medicaluse case or question for which it was designed, such as identified bythe use case parameter 220. If, in this example, the patient fails totake a bG measurement for the lunch meal in response to a request 240for such a collection according to the schedule of the event 222, andhence the adherence criteria 224 for that event 237 fails to besatisfied, the processor 102 in response to the associated adherenceevent 242 can be programmed according to instructions in the collectionprocedure 70 to cancel all remaining events 237 in the schedule ofevents 222 for that day, mark the morning bG measurement stored in thedata file (such as data file 145 (FIG. 4) as invalid, and reschedule forthe schedule of event 222 for the next day. Other examples of furtheractions in which the processor 102 may take in response to an adherenceevent 242 may be to dynamically change the structured collectionprocedure by switch to a secondary schedule of event, which may beeasier for the patient to perform, provide additional events formeasurements to make up the missing data, change the exit criteria froma primary to a secondary exit criterion providing modified criterion(s),change the adherence criteria from a primary to a secondary adherencecriterion, fill in the missing data for the failing event with (anestimate from) historical data, perform a particular calculation to seeif the structured collection procedure 70 can still be successfullyperformed, send a message to a particular person, such as a clinician,of the failing event, provide a certain indication in the associateddata record 152 to either ignore or estimate the missing data point, andthe likes. In still another embodiments, the adherence criteria 224 canbe dynamically assessed, such as for example, based on one or morebiomarker values and/or input received from the user interface inresponse to one or more questions, via an algorithm which determineswhether the collected data provides a value which is useful inaddressing the medical use case or case. In this example, if thecalculated adherence value is not useful, for example, does not fallinto a desired range or meet a certain pre-define value, then furtherprocessing as defined by the resulting adherence event would then takeplace, such as any one or more of the processes discussed above.

The exit criteria 228 as mentioned previously above establishes therequirements for exiting or completing the structured collectionprocedure 70, so that the structured collection procedure 70 hasadequate contextual data to answer the medical question addressed by thestructured collection procedure 70. The exit criteria 228 can helpincrease the efficiency of the structured collection procedure 70 byminimizing the number of required samples needed to address the medicaluse case. By “addressing”, it is meant that sufficient patient data hasbeen collected in which the clinician 14 may render an assessment to themedical use case. In other embodiments, the assessment may be indicatedby a given confidence interval. A confidence interval is a group ofdiscrete or continuous values that is statistically assigned to theparameter. The confidence interval typically includes the true value ofthe parameter at a predetermined portion of the time.

As with the entry criteria 226, the exit criteria 228 can comprise oneor more of context specific exit criteria 244, procedure specific entrycriteria 246, and combinations thereof. Examples of context specificexit criteria 244 can include one or more variables to identify mood,desired blood glucose events (i.e., blood glucose level), to indicatestress, illness, contraindications, such as for example, hyperglycemia,hypoglycemia, vomiting, a fever, and the likes. Examples of procedurespecific entry criteria 246 can include one or more variables toidentify a number of events meeting the adherence criteria, biomarkervalues being in a desired pre-determined range and/or at a desiredpre-determined value, a desired disease state, desired disease status,no change in the biomarker after a pre-determined period, or nosignificant progress over a pre-determined period to a desired biomarkervalue, and the like. It is to be appreciated that in one embodiment theexit criteria 228 can establish the condition(s) needed to be met forentry criteria 226 of a second structured collection procedure 70. Forexample, upon having a suitable Insulin-to-Carbohydrate (I:C) determinedwith a first collection procedure, such as for example, structuredcollection procedure 70 b (FIG. 6B), running a structured test fordetermining the best time for administering a bolus in regards to astart of a meal, such as for example, structured collection procedure 70c (FIG. 6C), which needs a current I:C ratio, can be conditioned suchthat the processor 102 can implement automatically a schedule of eventsof the second structured collection procedure 70 c upon meeting the exitcriteria of the first structured collection procedure 70 b at someunknown time. In other embodiment, for example, the exit criteria 228 ofa first structured collection procedure 70 that is being run by theprocessor 102 according to the schedule of events 222 and the entrycriteria 226 of the second structured collection procedure 70 both canbe based on the same one or more contraindications, such as mentionedabove. In such an embodiment, upon occurrence of a contraindicationbeing provided to and/or detected by the processor 102, such as via theuser interface 146 and/or the biosensor 140, respectively, which in thisexample meets the exit criteria 228 of the first structured collectionprocedure 70, the processor 102 would automatically start the scheduleof events of the second structured collection procedure 70 as the entrycriteria 226 of the second structured collection procedure 70 has alsobeen met. An example of such a second structured collection procedure 70which can be started via exiting a first structured collection procedurecan be one which has a schedule of events 222 which requests a biomarkersamplings at a routine interval, e.g., every 30 minutes, every hour,every day at a particular time, etc., until the contraindication(s)clears (e.g., biomarker value(s) reaches a desire range or value,patient 12 indicates to processor 102 via user interface 146 no longerhaving a contraindication(s), expiration of a predefined period, etc.).Such an embodiment is useful if recording the context and values of theevents after the occurrence of the contraindication(s) is a desire andin which the first collection procedure should be exited when acontraindication(s) occurs.

The exit criteria 228 can be a single criterion or multiple criteriathat establish the conditions to exit the structured collectionprocedure 70. The conditions are provided in a preferred embodiment suchto ensure that adequate contextualized biomarker data has been obtainedto answer the medical question being addressed by the collection method.For example, such that a predetermined number of valid samples have beenacquired, or that the variability in the samples is below apredetermined threshold. Therefore, it is to be appreciated that the enddate and/time of the collection procedure 70 may be dynamic and bechanged automatically by the processor 102 if the predefinedcondition(s) of the exit criteria 228 is not satisfied. Likewise, theconditions of the exit criteria 228 may be dynamic and be changedautomatically be the processor 102 such for example if a particularadherence criteria 224 is satisfied or not satisfied. For example, inone embodiment if adherence criteria 224 for a particular collectionevent 237 is met, then the processor 102 is instructed to use a firstexit criterion and if not met, then the processor 102 is instructed touse a second exit criterion that is different from the first exitcriterion. Accordingly, until the exit criteria 228 is satisfied, theend date and/time of the structured collection procedure 70 can be atsome unknown time in the future. In another embodiment, the exitcriteria 228 can be assessed after patient data has been collected, suchas, on historical patient data.

It is to be appreciated that the entry and exit criteria 226, 228together with the adherence criteria 224 can help to reduce both thetime to perform the structured collection procedure 70 and the expenseassociated with the collection by defining one or more of the acceptableconditions, values, structure and context needed to perform the scheduleof events 222 in an effort to make every collection event 237 countand/or reduce consumption of test strips 30 with unneeded collectionsthat do not help address the medical use case or question. Hereafterreference is made to FIGS. 6A-6E.

Structured Collection Procedure Examples

FIGS. 6A-E illustrate examples of some structured collection procedures70 a, 70 b, 70 c, and 70 d depicting their functions which can easily betranslated by one of ordinary skill in the related art into instructioncode which may be implemented on any one of the devices the abovedescribed devices 18, 24, 25, 26, 28, 36, 52. Therefore, for brevity, nodiscussion is provided in regard to pseudo-code or actual code relatingto these illustrated functions.

FIG. 6A diagrammatically illustrates an embodiment of a structuredcollection procedure 70 a used to obtain contextualized biomarker datafrom a diabetic patient. The horizontal axis shows the performance times238 of the various events 237, and the vertical axis shows adherencecriteria 224 without values. In the illustrated embodiment, the events237 can include recording information regarding a meal 248 and sleep 250in which to provide context 252 for the five-biomarker samplings 254also events 237 that are part of the schedule of events 222. In thisexample, the adherence criteria 224 for the meal 248 can be a valuewhich must be greater than a minimum value, e.g., for a carbohydrateamount. The entry criteria 226, for example, can comprise a biomarkervalue being above a particular value such as required to meetcontextualization requirements to begin the structured collectionprocedure 70 a. The exit criteria 228 as well can comprise a biomarkervalues being below a particular value such as also required to meetcontextualization requirements to end the structured collectionprocedure 70 a. Such a structured collection procedure 70 is useful forhelping to address a number of medical use cases.

GLP1 Structured Collection Procedure

For example, several epidemiological studies have confirmed thatelevated postprandial glucose (PPG) levels are a significant predictorof cardiovascular mortality and morbidity in type 2 diabetes (T2D). Forthis reason, there is a family of human once-weekly long actingglucagon-like peptide-1 (GLP 1) drugs which can be prescribed to T2Dswho show high post prandial bG values. These GLP 1 drugs are similar tothe natural hormone GLP-1 which has a key role in blood sugar regulationby stimulating insulin secretion and suppressing glucagon secretion.Therefore, a structured collection procedure 70 can be provided in oneembodiment which proposes an intensive measurement of bG values duringthe time after one or more meals over time allows therapy efficacy to beshown by means of observed reduced postprandial bG values. Based on suchobserved values, doses recommendation for a GLP 1 drug and/or whether aparticular GLP 1 drug is the right drug at all for the patient can bedetermined.

For example, the structured collection procedure 70 could be provided ona collection device 24 for when a patient has been prescribed toadminister a particular drug, e.g., a GLP 1 drug. In the case of a GLP 1drug, in which determination of drug efficacy is desired, the entrycriteria 226 for such a structured collection procedure could then bethat the patient must affirm to the processor 102 in response to aquestion displayed on the display 108 to perform the structuredcollection procedure 70 over a period of time (e.g., over the next 4 to24 weeks) and/or the processor 102 has determined that the mean PPGlevel of the patient from prior post prandial bG values over a period(e.g., week, month, etc.) are high (e.g., greater than 141 mg/dl). Stillother factors could be used as the entry criteria 226, such as fastingblood glucose being more than a certain value, e.g., 126 mg/dl or lessthan a certain value, e.g., 240 mg/dl.

After the conditions of the entry criteria 226 have been satisfied andconfirmed by the processor 102, the schedule of events 222 is thenautomatically run by the processor 102. The schedule of events 222 wouldspecify desired collection events 237 in which the processor 102 wouldautomatically prompt the patient for entering post prandial bG valuesafter breakfast, lunch, and dinner (i.e., performing a bG measurement ona sample provided to a test strip that is read by the measurement engineand provided to the processor for storing in a data record and display).As customized by the prescribing physician, the schedule of events 222could also define a collection event 237 with a performance time 238 inwhich the patient must administer the drug as well as to provide areminder of the dosage and a request 240 for confirmation from thepatient when the drug has been administered. For example, the processor102 in executing the schedule of events 222 would automatically promptthe patient to administer dosages at the times specified by thecollection events 237 in the schedule of events 222, e.g., 10 mg ofTaspoglutide on a certain day of the week, and then after a period, asecond dosage according to a second interval, e.g., after 4 weeks, then20 mg also on a certain day of the week. A collection event 237 couldalso be defined in the schedule of events 222 in which the processor 102makes a request on the display 108 for information, such as whether thepatient is feeling well, to provide an indication of energy level, toprovide an indication of size of meals consumed, and the like.

A condition(s) for the adherence of each entered post prandial bG valuecould be provided via the use of adherence criteria 224 in which anypost prandial bG value entered (i.e., measured) an amount of time beforeor after the prompting, e.g., a testing window of ±30 minutes, such ameasured value would not be accepted as a valid measurement for theschedule of events 222 by the processor 102. In one embodiment, theprocessor 102 can take further action automatically based on theadherence criteria 224 assessment preformed automatically by theprocessor 102. For example, if a bG measurement was taken before ameasurement prescribed by a collection event in the schedule of events222 and outside the defined testing window, e.g., −30 minutes before thecollection event time, the processor 102 in such a case willautomatically notify the patient that a measurement is still needed atthe prescribed time as the previous measurement was not accepted sinceoutside the testing window. Likewise, if after the testing window, e.g.,the collection event time +30 minute, the processor 102 canautomatically notify the patient that the previous measurement was notaccepted since outside the testing window and provide encouragement onthe display 108 to the patient to make an effort take a measurementwithin the testing window.

The exit criteria 228 for such a GLP 1 structured collection procedure70 could be an indication that the mean bG value, in using a minimumamount of time (e.g., days, weeks, months, etc.), a minimum number ofaccepted measurements, or both, has reached a desire value. Likewise,the exit criteria 228 could be an indication that the mean bG value,after a maximum amount of time (e.g., days, weeks, months, etc.), amaximum number of accepted measurements, or both, has not reached adesire value. Still further, the exit criteria 228 can be other factorswhich indicate that the drug or dosage is not at all right for thepatient, such as the patient responding as having nausea and/or vomitingeach day for a minimum number of days in response to a collection eventfor such information prompted by the processor 102 on the display 108.Still other factors could be used as the exit criteria 228, such asfasting blood glucose being less than a certain value, e.g., 126 mg/dlor greater than a certain value, e.g., 240 mg/dl. The data collectedfrom such a drug base structured collection procedure 70 can then beused by a physician to make a dosage recommendation for the GLP 1 drugand/or determine whether the particular GLP 1 drug is the right drug ornot for the patient.

Another example is diagrammatically depicted by FIG. 6B which shows astructured collection procedure 70 b which has a defined medical usecase parameter 220 indicating that the procedure can be helpful fordetermining suitability of an insulin to carbohydrate (I:C) ratio. Asillustrated, the entry criteria 226 is defined as having the patientsimply acknowledge guidance 230 of selecting a fast-acting meal, to notethat the insulin dose is calculated with the current I:C ratio as wellas agreeing not to exercise, take additional food or insulin during thetesting period. For example, the processor 102 can present on thedisplay 108 such guidance 230, which the user can then acknowledge afterreading with either a “Yes” or a “No” entered via using the userinterface 146 for the desired entry choice. If the user enters “Yes”,then the entry criteria 226 is satisfied, and the processor 102automatically starts the schedule of events 222 defined in thestructured collection procedure 70 b. In another embodiment, the entrycriteria 226 may be or include satisfying a request 237 for selecting afast-acting meal. For example, the request 237 for selection can be theprocessor 102 displaying on the display 108 a selection menu providing alisting of fast-acting meals to which input of such a selection via theuser interface 146 is needed. For example, selection of a fast-actingmeal may be made via a press of one of the buttons 147, 149 or via thetouch screen interface if provided by display 108. Such a selection canthen be stored in memory 110 of the collection device 24 such as setupdata 163 (FIG. 4) which may be part of the data file 145 (FIG. 4) forthe structured collection procedure 70 b. In an alternative embodiment,a particular fast-acting meal may be recommended by the structuredcollection procedure 70 b.

As shown, the schedule of events 222 can comprise one or more events,such as the plurality of events 237 a-k illustrated and with each havingassociated performance times 238 a-k and requests for action 240 a-k. Asshown, the requests for action 240 a-c, and 240 f-k are requests for theuser to take a bG level measurement, request 240 d is to take an insulindose, and request 240 e is to eat the fast acting meal. Also shown isthat events 238 f-k each have an adherence criteria 224, which must bemet if the data for events 238 f-k are to be recorded in the data file145. In this example, the adherence criteria 224 requires that theactions 240 f-k be completed within ∀20 minutes of their correspondingperformance times 238 f-k in order for a data record 152 recording thereceived value(s) for the corresponding event 237 f-k to count towardscompleting the collection procedure 70 b. In one embodiment, theprocessor 102 will make each of the requests 240 a-k at their associatedperformance times 238 a-k in order to obtain resulting data values e.g.,data values 256 a-k (FIG. 4) at the time the requests are performed.

For example, the processor 102 can prompt the patient 12 with a request240 a to take a bG level (biomarker) measurement at performance time 238a. The resulting measurement when received by the processor 102, such asautomatically from the measurement engine 138 after reading the teststrip (biosensor) 140 for the desired biomarker, is then recordedautomatically by the processor 102 in the date file 145 as acorresponding data value 256 a for the associated event 237 a. Foractions 240 d and 240 e, at a required time, the processor 102 canautomatically prompt the patient 12 to take the prescribed action at therequired time, and again automatically prompt the patient thereafter toconfirm that the required action has been taken, or that a predefinestatus has been achieved. A date-time stamp 169 can also be provided inthe date record 152 automatically by the processor 102 upon triggeringof the requests 240 a-k, acknowledgement of the requests 240 a-k, uponcompletion of the event 237 a-k, upon receiving a data value 256 a-k forthe event 237 a-k, and combinations thereof. Additionally, in anotherembodiment, the patient 12 can record data values 256 a-k for one ormore events 237 a-k by entering the data directly into the device 24 viathe user interface 146, wherein the processor 102 stored the entereddata values/information in the associated data record 152 for the event237 a-k, or in other embodiments can record a voice message with theinformation for later transcription into digital data. In still otherembodiments, the patient 12 can be guided by the collection device 24 torecord data for an event 237 a-k using a paper tool 38.

As mentioned previously above, each event 237 can be a recording of abiomarker value, or a request for a required patient action that isnecessary in order to create a context for the biomarker value, such asfor example, meals, exercise, therapeutic administration, and the like.In the illustrated embodiment, the context 252 for completing events 237a-c is to establish a pre-prandial baseline and a no-trend condition,and for events 237 f-k to establish a post-prandial excursion and tail.Such context 252 for these events may also be associated with thecorresponding data records 152 for each event as contextual information156 (FIG. 4). Such information is useful later when reconstructing thedata and/or when there is a desire to know the context for which thedata record was created.

It is to be appreciated that any patient action taken outside of therequired requests for patient actions 240 a-k can also be recorded bythe processor 102 but will not be considered by the processor 102 aspart of the collection procedure 70 b. Data 256 a-k for events 237 a-kthat are prospective can be identified based on a type of event, thetime of the event, the trigger of the event, and combination thereof.Each of the performance times 238 a-k can be fixed or variable based onprior data. Some of the event 237 a-k in other embodiments can also be apast, current, or a future event such as for meals, exercise, and thelike, or data values such as for hypoglycemic events, hyperglycemicevents, or data of a specific value of interest. In some embodiments,the events 237 a-k can be identified via a paper tool 38 that isprocedure based.

As also shown, the structured collection procedure 70 b will end if thecondition of the exit criteria 228 is satisfied. In this example, theexit criteria 228 is satisfied if at least three of the actions 240 f-kmet the adherence criteria 224. For example, the processor 102 mayprovide a unique identifier (e.g. one or more numbers, letters, and/orcharacters which will only appear once in the data file to identity dataassociated therewith, e.g., an incremental count, pointer, etc.) 167(FIG. 4) in the data file 145 for each event 237 a-k performed and towhich satisfied the adherence criteria 224 if required. In theillustrated embodiment of FIG. 4, events 237 a-c and 237 e-k eachreceive a unique identifier but not event 237 d, e.g., <null>, since notsatisfying an associated adherence criteria (not shown). In addition,analysis logic 258 and resulting recommendations 260 can also beprovided in the structured collection procedure 70 b which the processor102 may apply automatically to the data collected upon satisfying theexit criteria 228 in one embodiment.

Similar features are also provided in the examples illustrated by FIGS.6C and 6D, wherein FIG. 6C depicts a structured collection procedure 70c which has a defined medical use case parameter 220 indicating that theprocedure is helpful for determining suitability of a bolus in regardsto a meal start. Likewise, FIG. 6D depicts a structured collectionprocedure 70 d which has a defined medical use case parameter 220indicating that the procedure is helpful for determining suitability ofan exercise equivalent to a carbohydrate intake. In addition to theabove examples, other such structured collection procedures may bedesigned to address other various medical use cases such as, forexample, the following: determining the effects of eating a particularfood on a biomarker level of a patient; determining the best time totake medication before and/or after a meal; and determining the affectof a particular drug on a biomarker level of a patient. Still otherstructured collection procedures can be provided which may be useful inaddressing questions concerning how best to initialize therapy for apatient, finding a determination of status of a patient diseaseprogression, finding the best ways to optimize a patient therapy, andthe like. For example, the clinician 14 can define and/or use apre-defined structured collection procedure 70 which looks at factorswhich may have an effect on the therapy of the patient. Such factors caninclude, for example, stress, menstrual cycle, pre-dawn effect,background insulin, exercise, bolus timing with respect to a meal, basalrate, insulin sensitivity, post-prandial behavior, and the like.

FIG. 6E shows a diagram structured collection procedure 70 comprisingone or more multiple sampling groupings 262 each comprising a recurringschedule of events 222 provided between the entry criteria 226 and theexit criteria 228. In this example, the schedule of events 222 comprisesone or more events 237 occurring each day at consistent times of day. Asthe structured collection procedure 70 in the process of obtainingcontextualized biomarker data from a diabetic patient 12 can span overmultiple days, even week and/or months before the exit criteria 228 ismet, one or more checks 264, such as for parameter adjustment, and/orevaluation of whether to re-run the sampling groupings 262, can also beprovided between the entry and exit criteria 226, 228 in one embodiment.The duration between such checks 264 can be used for physiologicalsystem equilibration, evaluation of treatment efficacy, or convenience.For example, either between each sample grouping 262 or after apredefined number such sampling grouping 262 (as shown), an analysis forthe check 264 can be performed by the processor 102 to determine whetheran adjustment to any parameter in the collection procedure 70 is needed.

For example, such analysis may be either for a parameter optimization orefficacy assessment. For the parameter optimization, the processor 102can run calculations on the samples provided within a previous scheduleof events 222 or sample grouping 262, using information from prioroptimizations, clinician set parameters, and a collection or therapystrategy, recommends a new parameter value. For the efficacy assessment,the processor 102 can evaluate data not utilized by the optimizationanalysis. Additionally, it is to be appreciated that after a group ofsamples, i.e., sampling group 262, are taken the processor 102 can alsoevaluate the data from the sampling group 262, such as if such data isneed in order to alter/optimize a person's therapy. Adherence criteria224 can be applied to the perform this evaluation to the data of thesampling group 262. For example, a first adherence criteria 224 can beused by the processor 102 to assess whether a minimum amount of data isprovided by the sampling group 262 and if not, for example, thealteration/optimization of the patient's therapy will not take place.Another adherence criteria 224 could permit the processor 102 assesswhether the data is acceptable to permit an adjustment called for by thecheck 264, such as looking at spread of the data, whether these is toomuch variability (noise), as well as other data attributes to use thedata. In this example, if meeting such adherence criteria, thenprocessor 102 has assessed that there is minimum risk that adjusting aparameter of the procedure could readily result in a severe event, e.g.,hyper- or hypoglycemic event. Lastly, an adherence criteria can be usedby the processor to assess the exit criteria 228 based on the data ofsampling group, for example, the exit criteria is met when the data fromthe sampling group 262 satisfies the adherence criteria, such as forexample, discussed above, for the sampling group.

It is to be appreciated that collection or therapy strategies can becategorized into scale based (sliding or fixed) assessments or formulabased assessments. As input to the collection or therapy strategy, theprocessor 102 in one embodiment can utilize the data collected from apredetermined number of prior sample grouping(s) 262. This data can beeither used as individual points (only the formula based collection ortherapy strategies), or combined with filtering for use in a scale basedassessment. In another embodiment, for example, the result of a check264 performed by the processor 102 can also result in a status orrecommendation being provided by the processor 102 automatically. Suchstatus or recommendation may be e.g., a status of continuing withcurrent parameter values, a recommendation to change particularparameters, a recommendation to change the adherence and/or exitcriteria, a status that the processor 102 switched to a secondaryadherence and/or exit criteria based on the analysis performed on thedata from a prior schedule of events or prior sample grouping, or arecommendation to terminate the collection procedure, and the likes. Adiscussion of performing a structured testing method using a structuredcollection procedure according to an embodiment of the present inventionis provided hereafter with reference made to FIG. 7A.

Structured Testing Method

FIG. 7A depicts a structured testing method 300 for diagnostic ortherapy support of a patient with a chronic disease. The method 300 maybe implemented as instruction codes of a program running on a computerwith a processor and memory, such as preferably clinician computers 25(FIG. 2) as stand-alone software, as part of software 34, or as softwareprovided as a service by server 52 via a secure web implementation overpublic network 50. Upon a processor 76 executing the program from memory78 of the clinician computer 25, as one function among others, theprocessor 76 after receiving a query for a medical use case and/orquestion, searches memory 78, computer readable medium 40, and/or server52 for all structured collection procedures 70 a-d, which matches thesubmitted query in step 302. For example, the processor 76 may read themedical use case parameter 220 of each available structured collectionprocedures 70 a-d and using a conventional search algorithm (e.g., list,tree, heuristics, etc.), provide on a display 82 a selection choice forthose structured collection procedure matching the query in step 304 inone embodiment.

In one embodiment, the list displayed can reflect, for example, thestructured collection procedures 70 a, 70 b, 70 c, and 70 d availablefor use from the server 52. In still another embodiment, the list ofselection choices displayed can be dynamically created based on a typeof medical use case the clinician 14 wishes to investigate. For example,prior to step 302, a list of selectable medical use cases can bedisplayed on the display 82 by the processor 76. In such an embodiment,the clinician 14, using the user interface device(s) 86 may selectedfrom among the displayed medical use cases, for example, the medical usecase “Determining meal effect on patient's therapy.” After the clinicianmakes such a selection, which the processor 76 receives as input fromthe user interface device(s) 86, the processor 76 after using decisionlogic (e.g., if...then) provided by the software 34 would then displayin step 304, for example, structured collection procedure 70 b (e.g., astructured collection procedure to determine a more accurateinsulin-to-carbohydrate ratio) and 70 c (e.g., a structured collectionprocedure to determine bolus timing in regards to meal start), and notstructured collection procedures 70 a and 70 d, which are structuredcollection procedures unrelated to the medical use case. Likewise, a“show all structured collection procedures” could also be a choice amongthe displayed medical use cases, in which the complete list of availablestructured collection procedures would then be displayed in step 304. Inanother embodiment, step 302 may be skipped and the processor 76 in step304 can just provide a display of the structured collection procedures70 a-d available in memory 78 of the clinician computer 25.

In step 306, a clinician using the user interface devices 86 can selecta structured collection procedure 70 on the computer 25 for diagnosticor therapy support. For example, the selecting process can includechoosing from the list displayed in step 304, which provided one or morestructured collection procedures. After the clinician makes such aselection in step 306, which the processor 76 receives as input from theuser interface device(s) 62, the processor 76 of the computer 25retrieves automatically from an electronic component, e.g., computermemory 78, server 52, or computer readable medium 40, and displays theselected structured collection procedure 70 on display 82 for viewing.

It is to be appreciated that each structured collection procedures 70 a,70 b, 70 c, and 70 d is based on a medical use case and has parametersdefining entry criteria 226, a schedule of events 222, adherencecriteria 224, and exit criteria 228. As mentioned above, the entrycriteria 226 establish the conditions needed to be met prior toobtaining biomarker data from the patient. Each event 237 of theschedule of events 222 comprises a performance time, patient guidance toperform the event, patient actions, a request for information from thepatient, a request for collection of at least one type of biomarker datafrom the patient, and combinations thereof. The adherence criteria 224is used to qualitatively assess whether an event 237 performed accordingto the schedule of events 222 provided data which is acceptable toaddressing the medical use case upon which the structured collectionprocedure 70 is based. Additionally, as mentioned above, the exitcriteria 228 establish the conditions needed to be met prior to exitingthe structured collection procedure 70.

In step 310, after the processor 76 displays the selected structuredcollection procedure 70, the clinician 14, to meet the needs of thepatient 12 and/or interests of the clinician, may adjust any one of theparameters 222, 224, 226, and 228 which are also displayed on thedisplay 82. Safe guards may be implemented to ensure that only theclinician 14 can modify such parameters and/or run the software 34, suchas via password protection. The processor 76 receives any such changesto the parameters 222, 224, 226, and 228 as input via user interfacedevices 86 and saves the revised structured collection procedure 70 inmemory 78. Next, in step 312, the selected structured collectionprocedure 70 is prescribed on the computer 25 to the patient 12 by theclinician 14, wherein the processor 76 of the computer 25 provides asoutput the selected structured collection procedure 70 to the patient 12to perform. For example, in step 314, the prescribed structuredcollection procedure 70 is implemented electronically on a processorbased device, such as collection device 24, or any of the other abovedescribed devices 18, 28, and 36 (FIG. 1), as part of the software 34 orin other embodiment, portions thereof as part of paper tool 38.

In one embodiment, the prescribed structured collection procedure 70 maybe implemented from the clinician computer 25 (FIG. 2) to the collectiondevice 24 via communication link 72, via the public network 50 through awebpage and/or made available for downloading on server 52. In stillother embodiments, the prescribed structured collection procedure 70 canbe provided through the computer readable medium 40 and loaded by one ofthe devices 18, 24, 28, and 36, downloaded from another one of thedevices 18, 24, 25, 26, 28, and 36, or downloaded via cell phone ortelephone connection from server 52. Notice that anew/updated/prescribed structured collection procedure 70 available foruse on the devices 18, 24, 25, 26, 28 and 36 may be provided in anystandard fashion, such for via postal letters/cards, email, textmessaging, tweets, and the likes.

Customizing a Structured Collection Procedure

FIG. 7B conceptually illustrates one example of a pre-defined structuredcollection procedure 70, which has a defined medical use case parameter220 indicating that the procedure is helpful for medical use cases orquestions which need to know the trends in blood glucose (bG) levels ofa patient and/or the relationships between blood glucose values and timeof day, meal size, and energy level. As mentioned above previously, theuse case parameter 220 can be used as an identity tag in which theprocessor 102 may locate the associated structured collection procedure70 in response to a search query, such as, for entered use case orquestion. For example, the search query can be entered into thecollection device 24 via the user interface 146 and/or received from theclinician computer 25. Such a search query may result from a desire toknow which uses case can be addressed by the structured collectionprocedures 70 currently available on the collection device 24, or toknow which structured collection procedure 70 would be useful to addressa particular use case or question. Therefore, the use case parameter 220in one embodiment permits a structured collection procedure 70 to beautomatically chosen by the processor 102 from a plurality of structuredcollection procedures 70 a-d, such as provided in memory 110, memory 78,computer readable medium 40, and/or server 52 based on a selection, suchas from a displayed list on the display 108 provided by the processor102, or from input received by the processor 102 from the user interfaceof a defined medical question. In other embodiments, the use caseparameter 220 may also indicate the structured collection procedure 70is also useful for showing relationships between bG level values andtime of day, meal size, and/or energy level.

In one embodiment, the pre-defined parameters of the structuredcollection procedure 70 can be displayed for modification/customizationby the processor 102 of the collection device 24 on the display 108and/or by the processor 76 of the clinician computer 25 on the display82 by an authorized user. Such an authorized user may be identified, forexample, on the collection device 24 and/or the clinician computer 25 bya password entered via the user interface 146, 86, respectively. In suchan embodiment, the pre-define parameters of structured collectionprocedure 70 can be displayed on the display 108, 82 in whichcustomizable parameters can provide editable or selectable variables viadrop-down boxes with various selection choices, radio buttons, checkboxes, formatted fields requesting a specific type of information(mm-dd-yyyy, number, letter, etc.), text boxes to enter messages to bedisplayed, and the likes. The structured collection procedure 70 can bedisplayed for editing in tabular format (as illustrated) in oneembodiment or in a sequential manner listing one parameter at a time ina scroll-through fashion in another embodiment. In still anotherembodiment, structured collection procedures can be provided whichcannot be modified.

As shown by FIG. 7B, the structured collection procedure 70 may furthercomprise parameters defining one or more criteria setting the conditionsneeding to be met by the patient 12 to start of the structuredcollection procedure, i.e., entry criteria 226, to end the structuredcollection procedure i.e., exit criteria 228, and combinations thereof.In one embodiment, the processor 102 of the collection device 24 usesthe one or more criteria to automatically start, evaluate, and end thestructured collection procedure 70 if the condition(s) defined by thestructured collection procedure are met. In still another embodiment,adherence criteria 224, which are the conditions needing to be met inorder for the collected datum/data to be accepted, can also be providedin the structured collection procedure 70.

As also shown in FIG. 7B, the structured collection procedure 70 furthercomprise parameters defining one or more (collection) events 237 whichtogether form the schedule of events 222. Each of the events 237comprises one or more requests 240, e.g., for a measurement from themeasurement engine 138 of a biomarker value for a sample provided to thebiosensor 140, and/or for information to be entered by the patient viathe user interface 146 such as in response to a question presented bythe processor 102 on the display 108. In the illustrated embodiment, therequests 240 are for a bG measurement, a meal size indication (S, M, orL), and an energy level indication (1, 2, 3, 4, 5), in which 1 is lowestand 5 is highest. Other such requests 240 can include indicating whetherthe patient exercised, indicating a particular food that was consumed,indicating which medicine was administered, indicating dosage of themedicine administered, and the like may also be provided in otherstructured collection procedures 70. In the illustrated embodiment, thecollection events can be customized by selecting which request 240 theprocessor 102 should perform via a yes/no selection box.

The structured collection procedure 70 may also include guidance 230 andtiming or performance time 238 associated with each of the collectionevents 237 as well as with each of the entry, exit, and adherencecriteria 226, 228, and 224. Such guidance 230 is provided by theprocessor 102 to the display 108 upon the occurrence of the associatedcollection event 237 or other parameters. For example, a collectionevent 237 for a bG measurement before breakfast may also have a request240 for an indication of the energy level of the patient. Therefore, inthis example, the associated guidance 230 which states, “Please indicateenergy level” is provided on the display 108 by the processor 102. It isto be appreciated that the guidance 230 is a text box, field, area,which enables for information to be provided to the patient to help thepatient in performance of the structured collection procedure 70. Inthis example, selection of a number from 1 to 5 may be made via press ofone of the buttons 147, 149 or via the touch screen interface ifprovided by display 108 as a data entry for such a request 237, which isthen stored by the processor 102 in memory 110 of the collection device24 as part of a data file 145 (FIG. 4) for the structured collectionprocedure 70.

The timing parameter 238 of the structured collection procedure 70 isused to specify for any one of the associated collection event 237, theentry, exit, and adherence criteria 226, 228, 224, either a specificdate and/or time (mm-dd-yyyy, hh:mm), or a period (n) after a precedingcollection event in which to perform the associated collection event.The periods n₁, n₂, n₃ in the illustrated embodiment for the respectivecollection events 237 indicate hours, but in other embodiments can beindicated in minutes or seconds. In another embodiment, the timing orperformance time parameter 238 for an associated collection event 237and for the entry, exit, and adherence criteria 226, 228, 224 can bemodified by another collection event and/or by the criteria.

For example, in the illustrate embodiment, the entry criteria 226 ismodified by the adherence criteria 224 by adding a day if the guidance230 provided in the form of a question “Are you willing to conduct atest over 3 consecutive days?” is not affirmed by the patient 12 e.g.,via a “No” selection provided on the collection device 24. In thisillustrated example, the “Affirms guidance” may be a drop down selectionprovided in a combo box for customizing the adherence criteria 224 ofthe associated collection event 237, which when selected causes theprocessor 102 to wait for the accepted/not accepted input (e.g., viabuttons 147, 149) before executing the remaining logic (“if not add 1day to timing”) of the adherence criteria 224. Still further in thisexample, the processor 102 in accordance with the logic provided in theadherence criteria 224 associated with the exit criteria 228, can setthe timing or performance time parameter 238 of the exit criteria 228 tothe date (mm-dd-yyyy) that is 3 days after completing the entry criteria226. It is to be appreciated that the various possible combinations oflogic statements which may be performed by the structured collectionprocedure 70 can be pre-defined and selected by a drop down box in orderto be customized in one embodiment, and/or logic statements can be builtin another embodiment.

The structured collection procedure 70 can also includes an optionsparameter 232 associated with each of the collection events 237 as wellas with each of the entry, exit, and adherence criteria 226, 228, 224.The options parameter 232 can have a customizable value(s) to governwhether the data and/or results of the associated collection event 237or any of the other parameters e.g., entry, exit, and adherence criteria226, 228, 224, in the structured collection procedure 70 meets aparticular condition such that still further processing may be carriedout by the processor 102 if such a condition(s) is meet. For example,such options can be to have the processor 102 automatically send amessage to the physician indicating that the patient has started thestructured collection procedure 70 via satisfying the entry criteria226, or to provide a message to the patient and/or the physician if thepatient fails a collection event 237 by not satisfying an adherencecriteria, or to provide a message to the physician when the patientcompletes the structured collection procedure 70 when the exit criteria228 is satisfied, or combinations thereof. For example, such an optionsparameter 232 can have a global list of such actions which is selectedon the display 108, for example, by a selected value from a range ofvalues associated with each option. For example, the options for eachparameter can be customized via selecting from a drop down box havingoption choices (e.g., 1, 2, 3, 4, 5, . . . , A, B, C, etc.) and inwhich, for example, Option 1 of having the processor 102 provide amessage to the physician if the patient fails a collection event 237(e.g., by not satisfying an adherence criteria), is shown selected forthe before breakfast collection event 237. An example in the context ofpatient 12 being diabetic is provided hereafter to illustrate furthersuch features provided on a collection device 24 according to thepresent invention.

A typical patient with Type 2 diabetes may measure his/her blood glucoseonce per day after waking up in the morning. At a routine office visit,the patient's HbA1C result is found to be elevated. The physicianrecommends that the person goes through three days of intensifiedglucose monitoring, and selects the structured collection procedurewhich is useful for this purpose. The structured collection procedure 70is then customized as discussed above such that during these three dayscollection events 237 are defined with a number bG measurement requests240 such that the patient can be requested by the processor 102 tomeasure his/her blood glucose before and two hours (e.g., to n₁=2) afterbreakfast, before and two hours (n₂=2) after lunch, before and two hours(n₃=2) after supper, and at bedtime. Additionally, the patient 12 can berequested via other associated requests 240 for each collection event237 to provide an assessment of the relative size of the ingested mealsat the appropriate times as well as an indication how he/she feels withregard to energy level. In the illustrate embodiment of FIG. 7B, theprocessor 102 can request the indication of energy level with eachcollection event 237 and the assessment of the relative size of theingested meals every other collection event 237 (i.e., after the meal).Furthermore, the physician has provided a condition via adherencecriteria 224 of having to perform the meal assessment within ±30 minutesof period (n) of the associated collection event 237 in order for suchinformation to be useful in the assessment. Such information is usefulto contextualize the collected data and for the analysis performed onthe collected data.

Additionally, the physician would like to be notified when the patienthas failed to complete the “before breakfast” collection event 237.Therefore, to facilitate the notification option, the physiciancustomizes the structured collection procedure 70 by set the optionsparameter 232 associated with the “before breakfast” collection event,via a drop down box to “Send a message to the physician if adherencecriteria fails.” All other collection events 237 have their associatedoptions parameter 232 default to indicate that the processor 102 is notto take any additional action with regards to the options parameter. Itis to be appreciated that the above described features and arrangementsillustrated embodiment of FIG. 7B, provides a simply and convenientinterface and method for customizing a structured collection procedure,such as for parameter adjustments carried out in step 310 of method 300previously discussed above in reference to FIG. 7A.

Implementing and Performing a Structured Collection Procedure

FIG. 8A shows a flowchart of the method for implementing and performinga structured collection procedure 70 to obtain contextualized biomarkerdata from a patient 12 according to an embodiment of the invention. Itis to be appreciated that a number of structured collection procedures70 a-d (FIG. 2) prescribed in step 312 and implement in step 314 (FIG.7A) may be stored in memory 110 (FIG. 3) of the device 24 and selectedfor execution at any desired time. For example, upon pressing a certaincombination of the buttons 147, 149, the patient can select a desiredstructured collection procedures 70 a-c and the date when to start astructured collection i.e., a set mode function. For example, a daterange to choose from may be to begin the testing tomorrow and end attoday +90 days, which the processor 102 can also recorded in the datafile 145 (FIG. 4) as part of the setup data 163. In such animplementation, the processor 102 as instructed by the software 34 readsthe setup data 163 for the selected structured collection procedure 70and indicates on the display 108 that the device 24 is in a structuredtesting mode, for example, from one day before the chosen testing startdate until the end of the structured collection procedure.

It should be appreciated that multiple structured collection procedures70 a-d can be executed sequentially or simultaneously at any given time.However, in one embodiment, the software 34 permits the user only toschedule another structured collection procedure 70 if the start date islater than the end date of the current structured collection procedure70 being executed. The software 34 also permits the user to override ascheduled date for a structured collection procedure 70. If a structuredcollection procedure 70 is scheduled and the user enters the set modefunction again, the software 34 causes the processor 102 to display thescheduled date on the display 108 as the default date; if the user exitsthe set mode without modifying the date, the previously scheduled datestays active. If a structured collection procedure 70 has started, thesoftware 34 permits the user to enter the set mode and cause theprocessor 102 to cancel the current structured collection procedure 70.Upon cancellation, in one embodiment, the software 34 causes theprocessor 102 to de-tag (e.g., null the unique identifiers 167) the datarecords 152 in the data file 145 for the data collected for thecancelled structured collection procedure 70.

Upon reaching the procedure start in step 316 (FIG. 8a ), the processor102 evaluates the whether entry criteria 226 is met in step 318 to beginthe structured collection procedure 70 selected to obtain biomarker datato address a predefined use case or question (e.g., use case parameter220). In step 320, the processor 102 specifies requests 240 according totheir associated timing 238 for each event 237 in the schedule of events222 for the structured collection procedure 70. It is to be appreciatedthat the schedule of events 222 provides a sampling plan for biomarkerdata collection that is performed by the processor 102 to obtainbiomarker data in a predefined context. In performing the schedule ofevents 222 in step 320, the software 34 causes the processor 102 toassign a unique identifier (e.g. incremental count) 167 in a date record152 which corresponds to each event 237 in the structured collectionprocedure 70. Optionally, each criteria 226, 228, 224 may also beprovide with a date time stamp 169 to indicate when such criteria wassatisfied, if desired.

Adherence criteria 224 is then applied to the input received (e.g.,biomarker data or information) in response to an request 240 todetermine whether the input received meets the adherence criteria 224.When a structured collection procedure 70 has started, all datacollected according to requests 240 in the structured collectionprocedure 70 and which satisfy the adherence criteria 224, if requiredin step 322, are then assigned (tagged) in the data file 145 by theprocessor 102 with the unique identifier 167 in step 324. It is to beappreciated that the unique identifier also serves to associates thecollected data e.g., data values 256 with their event 237, the request240, and a date-time stamp 169 to indicate when the collection inresponse to the request 240 was received by the processor 102. While astructured collection procedure 70 is being executed, in one embodimentthe software 34 permits the user to perform a measurement on the device24 at any time without interfering with the episode.

In one embodiment, the software 34 permits reminders for biomarkermeasurements to be ‘snoozed’ as mentioned above for a period, such asfor example, 15 minutes and up to a number of times, for non-criticalmeasurements. In another embodiment, biomarker measurements or dataentries that are performed close enough in time to a request 240 in step320 are designed as valid measurements or data entry for the request 240by the software 34. As such, the processor 102 will tag the associateddata record 152 for the event 237 with the unique identifier 167 forsuch a biomarker measurement or data entry accordingly. In the case ofbiomarker measurements, if the measurement is accepted as valid for therequest 240, the software 34 causes the processor 102 to prompt the userto input additional information if needed by the structured collectionprocedure 70 to provide context 252 for data resulting from the request240. Such additional input, may include, for example, a rating of energylevel from 1 to 5, where 1 is low and 5 is high; meal size from 1 to 5where 1 is small and 5 is large, and exercises from yes or 1 to meanover 30 minutes, and no or 2 to mean less than 30 minutes. Suchadditional information or contextual information 156 when inputted viathe user interface 146 is stored by the processor 102 in the data file145 associated with the unique identifier 167 for the data event request240 requiring the additional information also in step 324.

In one embodiment, biomarker measurements determined by the processor102 as not being close enough in time to the data event request 240defined by the structured collection procedure 70 will not be taggedwith a unique identifier 167 in the data file 145 by the processor 102.Such is illustrated in the shown data file 145 with request 240 d anddata values 256 d not being associated with a unique identifier 167e.g., <null>. An example of a definition of ‘close enough in time to thecollection procedure’ as instructed by the structured collectionprocedure 70 and/or software 34 to cause the processor 102 to make sucha determination may be defined as being relative to a prescheduled timeor a snoozed time. For example, for pre-prandial measurements up to 15minutes in anticipation is acceptable; for post-prandial measurements,up to 10 minutes in anticipation is acceptable; and for bedtimemeasurements, up to 15 minutes in anticipation is acceptable. Otherdefinitions may be provided in other structured collection procedures 70and/or software 34.

In step 326, the processor 102 then evaluates whether the exit criteria228 for the selected structured collection procedure 70 is satisfied. Ifnot, then the processor 102 continues with performance the schedule ofevents 222 until the exit criteria 228 is satisfied. Upon satisfying theexit criteria 228, the collection procedure 70 ends in step 328. In oneembodiment, the structured collection procedure 70 may also end if instep 318, the entry criteria 226 is also not met.

In some embodiments, the structured collection procedure 70 can beconfigured for performance as a paper tool 38; diabetes software 34integrated into a collection device 24 such as a blood glucose meter 26;diabetes software 34 integrated into the computing device 36, such as apersonal digital assistant, handheld computer, or mobile phone; diabetessoftware 34 integrated into a device reader 22 coupled to a computer;diabetes software 34 operating on a computer 18, 25 such as a personalcomputer; and diabetes software 34 accessed remotely through theinternet, such as from a server 52. When diabetes software 34 isintegrated into a collection device 24 or a computing device 36, thediabetes software 34 can prompt the patient to record diary informationsuch as meal characteristics, exercise, and energy levels. The diabetessoftware 34 can also prompt the patient to obtain biomarker values sucha blood glucose values.

GUI Interface Providing a Selectable Structured Collection Procedure

FIG. 8B shows a method of implementing the structured collectionprocedure via a graphical user interface provided on a collection device24, which when executed on the collection device, cause the processor102 to perform the following steps. Upon pressing a certain combinationof the buttons 147, 149, the patient 12 can scroll to the structuredcollection procedure 70 available for selection in a list 329 providedby the processor 102 on the display 108 of the collection device 24 instep 330. If desiring to start the structured collection procedure, thepatient 12, for example, selects via pressing an OK button 151 in step332, the desired structured collection procedure 70. In this example,the entry criteria 226 (FIG. 6) of the structured collection procedure70 provides information in step 334 which the processor 102 displays tothe user on the display 108. After reading the displayed information,the user presses any button in step 336 in which the next procedure inthe entry criteria 226 is performed by the processor 102. In thisillustrated example, as part of the entry criteria 226, a question isthen asked in step 338 by the processor 102. If the patient 12 is stilldesirous of starting the structured collection procedure, the patient 12selects the OK button 151 in step 340; otherwise, any other press viabutton 147, 149 will cause the processor to go back to the list 329,thereby stopping the set-up procedure for the structured collectionprocedure 70.

After the patient 12 presses the OK button 151, the processor 102 instep 342 will provide on the display 108 an alarm clock 343 for settingthe time to begin the selected structured collection procedure 70. It isto be appreciated that all the required events 237 for biomarkersampling, patient information, etc., is automatically schedule by theprocessor 102 in accordance with the schedule of events 222 for thestructured collection procedure 70 in which timing, values, questions,etc., therein may have been adjusted by the clinician 14 as discussedpreviously above in reference to FIGS. 7A and 7B. Therefore, other thanentering the start time as permitted by the entry criteria 226, no otherparameter adjustments in the structured collection procedure 70 isrequired by the patient 12 (or permitted in one embodiment).

In the illustrated embodiment, the patient in step 344 can adjust thestart time of the structured collection procedure for the next day,e.g., Day 1, via buttons 147, 149. Upon confirming the start time instep 346 via pressing the OK button 151, the start time is recorded inmemory 110 as part of the setup data 163 in the data file 145 (FIG. 4)for the structured collection procedure 70 by the processor 102. Theprocessor 102 then displays the selection list 329 on the display 108 instep 348, thereby completing the set-up procedure, which satisfies theentry criteria 226, and indicates on the display 108 that the collectiondevice 24 is in a structured testing mode 349.

It should be appreciated that in on embodiment multiple structuredcollection procedures can be executed sequentially or simultaneously atany given time, and hence in one embodiment the mode 349 provided on thedisplay 108 will indicated which structured testing is being performed.However, in one preferred embodiment, the software 34 does not permitsthe user to schedule another structured collection procedure, unless thestart date is later than the end date of the current structuredcollection procedure being executed via the user interface 146. It is tobe appreciated that processor 102 may re-schedule the followingstructured collection procedures automatically if the current structuredcollection procedure is still running due to the exit criteria 228 notbeing met. The software 34 in another embodiment may also permit theuser to override a scheduled date for a structured collection procedure.If a structured collection procedure is scheduled and the user entersthe set mode function again, the software 34 causes the processor 102 todisplay the scheduled date on the display 108 as the default date; ifthe user exits the set mode without modifying the date, the previouslyscheduled date stays active. If a structured collection procedure hasstarted, the software 34 permits the user to enter the set mode andcause the processor 102 to cancel the current structured collectionprocedure, if desired.

In step 350, an alarm condition 351 can be provided by the processor 102the next day (as indicated by the symbol Day 1) as was set in theabove-mentioned procedure the previous day (as indicted by the symbolStart Up). Upon the user selecting any button 147, 149, 151 in step 352,the processor 102 as instructed by schedule of events 222, provides afirst scheduled event 237 which is information 353 to be displayed ondisplay 108 in step 354, which the patient 12 acknowledges with anybutton 147, 149, 151 being pressed in step 356. Next in step 358, theprocessor 102 is instructed by the schedule of events 222 to execute asecond scheduled event, which is to display on the display 108 aquestion 359 for the patient, which the patient 12 acknowledges with anybutton 147, 149, 151 pressed in step 360. In the illustrated embodiment,the patient in step 362 indicates the start time of breakfast in minutesfrom the wake up alarm 351 previously acknowledged in step 352. Uponconfirming the meal start time in step 364 to the processor 102, viapressing the OK button 151, the meal start time is recorded in memory110. For example, the meal start time is recorded in the data file 144in the associated data record 152 as data for the event 237 by theprocessor 102. Additionally, in step 366, the processor 102 displays tothe patient 12 the information regarding the timing for the nextschedule event as a reminder. In step 368, upon reaching the nextscheduled event indicted by the schedule of events 222, the processor102 provides a request 240 on the display 108 for the patient to take ameasurement, e.g., a blood glucose measurement. Additionally, in step370, the processor 102 also makes a request 240 for information on thesize of the meal that is to be ingested as required by the schedule ofevents 222 in order to provide contextual information 156 to themeasurement value.

As mentioned above previously, for each event the software 34 causes theprocessor 102 to assign a unique identifier (e.g. incremental count) 167(FIG. 4) to the data of each request 240 provided in the schedule ofevents 222 which meet the adherence criteria 224 in the associated daterecord 152 for the event 237. Therefore, while the structured collectionprocedure is being executed, the software 34 permits the user to performa measurement on the collection device 24 at any time out side theschedule of events 222. Such a measurement since not being performedaccording to a request 240 will not be evaluated for the adherencecriteria 224, and thus will not be provided with a unique identifier 167in the date file but will only be provided with a date-time stamp andits measurement value. Such data is still recorded in the data file 145,as such data may still be useful for another analysis.

In another embodiment, the software 34 also permits reminders forbiomarker measurements, such as provided in step 238. For example, inone embodiment, the processor 102 provides an alarm and/or alert messagefor a reminder via the indicator 148 and/or on the display 108,respectively, to provide a measurement. For example, at the time 238 ofa particular request 240 for taking a biomarker measurement (orreading), the processor 102 prompts the patient 12 by al leastdisplaying on the display the message, “It is now time for yourreading.” An audible alarm and/or tactile alarm (vibrations) can beprovided by the processor 102 via indicator 148 in another embodiment.For example, in one embodiment, the collection device 24 will providesuch a prompt even when already powered on, such as by the patient 12for another reason, e.g., to conduct a non-scheduled event, when in, forexample, a window of time in which to take the requestedmeasurement/reading, or even when powered downed, such as in a standbymode, by waking up to provide the reminder via the prompt. In anotherembodiment, the provided reminder or prompt can be ‘snoozed’ for apre-defined period as mentioned above, that still falls within thewindow of time in which to take the requested (critical)measurement/reading such as for example, 15 minutes or any other suchsuitable time that falls in the window of time. It is to be appreciatedthat the snooze feature for a measurement/reading that is consideredcritical to the structured collection procedure 70, e.g., ameasurement/reading needed for helping to address the medical use caseor question, needed to meet adherence criteria 224, and/or needed insubsequent analysis for some determination, etc., the snooze featurewill not extend the request 240 beyond the window of time provided bythe collection procedure 70 via, e.g., adherence criteria 224 for therequest 240. For example, in one embodiment one or more events 237 inthe schedule of events 222 can be pre-defined as critical via use of theoptions parameter 232 (FIG. 7B) provided in the structured collectionprocedure 70. For example, an event 237 which is designated as criticalis one that cannot be missed, but if missed can be replaced by anothersample already in the date file 145. In still another embodiment, thesnoozing can be up to a number of times, for non-critical measurements.For example, certain events 237 in the structured collection procedure70 could be designated as having a non-critical request 240, which canbe snoozed, such as via selecting such an option that is provided as oneof the options parameter 232 (FIG. 7B). The options parameter 232 inthis embodiment could for example provide the snooze option as well as aselectable time interval (e.g., 1-60 minutes, etc.) and a selectablenumber of times (e.g., 1-5, etc.) that the user is permitted to snoozethe request 240. In still another embodiment, the collection device 24permits for an alarm shut off i.e., the indicator 148 if providing thereminder (audible, vibratory) can be shut off for the entire window oftime via the user interface 146, but wherein processor 102 still acceptsthe measurement/reading as long as it is made in the window of time. Instill another embodiment, the collection device 24 provides a skipreading option also received by the processor 102 via a selectionentered using the user interface 146, e.g., from a list of selectableoptions, such as for example, snooze, alarm shut off, skip reading,provided on the display 108, in which again no reminder/prompt will beprovided as patient 12 has indicated to the processor 102 that he/shedoes not want to take that particular requested measurement/reading. Itis to be appreciated that selecting the skip reading selection optioncan result in an adherence event 242 resulting in further processing,such as discussed previously above in early sections, if adherencecriteria 224 had been associated with the event 237 prompting therequest 240.

In still another embodiment, the adherence criteria 224 can requirebiomarker measurements to be performed close enough in time to a dataevent request 240. Therefore, if such biomarker measurements areperformed within the period specified by the adherence criteria 224, theprocessor 102 can indicate that the measurements or data entry for theevent is acceptable and tags (i.e., assigns the unique identifier 167)the value of the biomarker measurement or data entry in the data file145 accordingly. In the case of biomarker measurements, if themeasurement is accepted as valid for the data event request 240 (i.e.,meets the adherence criteria 224), the schedule of events 222 may causethe processor 102 to prompt the user to input additional information ifneeded by the structured collection procedure 70, such as mentionedabove regarding step 370 to provide contextual information 156 (i.e.,context) to the measurement received in response to a request 240.

Such contextual information 156 when inputted via the user interface 146can be stored by the processor 102 in the data file 145 associated withthe unique identifier 167 for the data event request 240 requiring theadditional information. Biomarker measurements determined by theprocessor 102 as not being close enough in time to the data eventrequest 240 as defined by the adherence criteria 224 will not be taggedin the data file 145 by the processor 102. Such is illustrated in theshown data file 145 (FIG. 4) with data event request 240 d and datavalues 256 d not being associated with a unique identifier 167. Anexample of a definition of ‘close enough in time to the collectionprocedure’ as instructed by the adherence criteria 224 to cause theprocessor 102 to make such a determination may be defined as beingrelative to a prescheduled time or a snoozed time. For example, forpre-prandial measurements up to 15 minutes in anticipation isacceptable; for post-prandial measurements, up to 10 minutes inanticipation is acceptable; and for bedtime measurements, up to 15minutes in anticipation is acceptable. Other definitions may be providedin other adherence criteria 224 for other events in the schedule ofevents 222 as well as in other structured collection procedure.

In the illustrated embodiment, the user uses the buttons 147, 149 toscroll to a selection, which is entered by the processor in the datarecord 152 for the associated request 240 via pressing Okay button 151in step 372. In one embodiment, the meal size can be indicated via anumber range, such as for example, from 1 to 5, where 1 is small and 5is large. In the illustrated embodiment, additional input for contextualinformation 156 regarding a rating of energy level from 1 to 5, where 1is low and 5 is high is requested in step 374, which is entered in thedata file 145 as mentioned previously above via the processor 102receiving input for the request 240 by using the user interface 146 instep 376. In other embodiment, other contextual information 156 mayinclude indicating whether the patient exercised and/or how long. Forexample, the user interface 146 may be use in which yes or 1 to meanover 30 minutes, and no or 2 to mean less than 30 minutes. In theillustrated embodiment, as the exit criteria 228 is now meet viasuccessfully performing steps 368-376, the structured collectionprocedure 70 ends in step 378, wherein the processor 102 again displaysthe list 329, such that the patient 12 may perform other tasks on thecollection device 24 if so desired. Reference is now made to FIG. 9hereafter.

Method of Contextualizing Biomarker Data

FIG. 9 depicts a method 388 of contextualizing biomarker data fordiabetes diagnostics and therapy support according to an embodiment ofthe invention. It is to be appreciated that in the previous embodimentsdiscussed above with reference to FIG. 8A and 8B, the contextualinformation 156 was requested and recorded with the associated biomarkervalue by the processor automatically during the structured collectionprocedure 70. However, in embodiments where such automation is notprovided on the collection device 24, and the patient is using a papertool 38, the collection data can be later associated with its contextualinformation 156 after, for example, the structured collection procedure70 is performed in step 390 to create at least data event values 256. Ifnot already done by the collecting device 24, such as in the case of adevice with limited memory and processing power or when recordings aremade on paper tool 38, such data may be provided to another one of thedevices 18, 25, 36 that is running the software 34 and has the abilityto associate at least the data event values 256 (FIG. 4) with theirrespective data event requests 240. This associating of at least thedata event values 256 with their respective data event request 240, thedate-time stamp 169, and the contextual information 156 results incontextualized (self-monitoring) data 170 in step 392.

It is to be appreciated that data as used in structured testingaccording to the present invention deals with the prospective collectionof contextualized data. Considering FIG. 10A, in this example, theinherent advantage of context becomes clear when one considers theutility of having a subway map on the left-hand side without context andone on the right-hand side with context, which makes it possible toeasily navigate the system and travel from one place to another. In asimilar manner, contextualization can play an important role indiabetes. Context associated with data, for example, can be due totherapy, an event (such as meals, exercise, an event 237, request 240,etc.), and time of request for data collection itself (e.g., timing238). As such, any data collected by the patient with measured valuescan be contextualized by being associated with one or more the abovementioned factors e.g., therapy, events, and time, each of which arediscussed further hereafter.

Therapy can be defined, for example, as an on-going treatment intendedto alleviate the patient's impaired glucose control. This treatmentgenerally involves anti-diabetic agents such as insulin, oralmedications, and diet and exercise. A therapeutic (or a therapeuticcombination) has a specific pharmacodynamic effect on a patient'sglycemia owing to different mechanisms of action. A change in either thedose(s) of the therapeutic(s) or a change in the therapeutic(s) itself,will lead to a change in the patient's glucose control. Consequently,the collected bG data is strongly linked to underlying therapy and doseand this information is used to contextualize the data. A change in doseor therapeutic will lead to a different context. It is to be appreciatedthat the therapy context can be set by the clinician 14 in consultationwith the patient at the time of designing the collection procedure 70,such as discussed previously above with regards to FIG. 5A.

In one embodiment, the events 237 in a collection procedure 70 caninclude specific conditions around bG measuring points that play a rolein altering the patient's normal glucose levels. As mentioned previouslyabove, events 237 can be meal or exercise based, and are pertinent fordata contextualization. In this context, the underlying assumption isthat the patient operates, more or less, under a well-defined schedule.At the time of creating the collection procedure 70, the patient 12 candiscuss lifestyle events with the clinician 14 so that the collectionprocedure 70 can be tailored according to the needs of the patient 12.As an example and with reference to FIG. 10B, consider a typicalcollection procedure 70 whereby the patient 12 does not exerciseregularly so that the majority of the events are meal based events thatconsist of breakfast, lunch, and dinner. Such a lifestyle of the patient12 leads to six candidate points for bG measurement (pre and post foreach of the meals) for the schedule of events 222 in the collectionprocedure 70. During the process of creating/customizing (FIG. 5A and/orFIG. 7B) of the collection procedure 70, the clinician 14 may specifythat the patient collect one or more or all of these points as per theschedule of events 222 of the collection procedure 70. Any datacollected in addition to these points, i.e., outside the requirements ofthe collection procedure 70, can be classified as non-collectionprocedure readings by the processor 102. In a similar manner, for a Type1 diabetic patient that exercises regularly, the clinician 14 cantailor/customize a collection procedure 70 to include additionalmeasurements around the exercise event. The event information, in thisexample, is then used to contextualize the data in an appropriate mannerdepending on the event 237.

Time represents the actual time at which a measurement is made and is inabsolute terms, e.g., date-time stamp 169 (FIG. 4). Additionally, timecan also be represented in terms of deviations, i.e., offset from aparticular event. As an example, a postprandial reading is taken at aspecific time after a meal and this time may be different acrossdifferent days. This scenario arises as the patient may not be able totake an event based reading t the same time every day. Consequently,there is a distribution of times at which the same measurement has beenmade at different days. The knowledge of this distribution can becomeuseful for analysis of such timing as well as the parameter timing 238in the collection procedure 70.

Additionally, with the contextualized data 170, the physiological stateof the patient 12 at the time of the measurement can be described. Thepatient's physiological state can influence a biomarker value, soknowledge of the patient's physiological state aids in the understandingof a biomarker value. The biomarker data can be contextualized becausethe biomarker data is collected in the context of predetermined eventssuch as last time of meal, meal type, meal distribution, exerciseinformation, sleep quality, sleep duration, waking time, and stressorssuch as illness and the like. Time-resolved data permits interpretingthe biomarker data in context with other information, such as compliancewith a structured collection procedure 70 and patient lifestyle events.

Referring again to FIG. 9, the contextualized data 170 is evaluatedusing adherence criteria 224 to generate accepted contextualized data395 that meets the adherence criteria 224 in step 394. As the adherencecriteria 224 can provide a basis for comparison of a data event value256 with a standard, so the data event value can be either accepted andused or rejected and not used, the adherence criteria 224 can be used tofilter data in one embodiment. In another embodiment, step 394 mayprecede step 392.

FIG. 11, for example, shows a diagram of accepted contextualized data395 intermingled with non-acceptable contextualized data 397. Thediagram vertical axis shows biomarker values 256 including context 252in the form of a biomarker setpoint, a biomarker upper limit, and abiomarker lower limit. The diagram horizontal axis shows performancetimes 238 of measurement requests 240 and a sleep period event 237 inwhich the actual sleep surpassed a recommended minimum amount of sleepas indicated by the dashed line. The accepted contextualized data 395 isthat which met the adherence criteria 224. The non-acceptablecontextualized biomarker data 397 are either not within the structuredcollection procedure 70 or did not meet adherence criteria 224. Byexcluding the non-acceptable contextualized biomarker data 397, theaccepted contextualized biomarker data 395 can help improvedecision-making. Statistical techniques can be used to view the acceptedcontextualized biomarker data 395 in a form that conveys additionalinformation to a clinician 14. Examples of statistical techniquesinclude regression methods, variance analysis, and the like. Hereafterfurther details about a preferred embodiment of the software 34 areprovided.

Software

As mentioned above in previous sections, the software 34 can operate onthe patient computer 18, the collection device 24, a handheld computingdevice 36, such as a laptop computer, a personal digital assistant,and/or a mobile phone; and paper tools 38. The software 34 can bepre-loaded or provided either via a computer readable medium 40 or overthe public network 50 and loaded for operation on the patient computer18, the collection device 24, the clinician computer/office workstation25, and the handheld computing device 36, if desired. In still otherembodiments, the software 34 can also be integrated into the devicereader 22 that is coupled to the computer (e.g., computers 18 or 25) foroperation thereon, or accessed remotely through the public network 50,such as from a server 52. Additionally, one or more collectionprocedures 70 can be provided as part of the software 34, provided asupdates to the software 34, or provide as individual files which can beoperated on and used by the software 34.

In the embodiment discussed hereafter, the software 34 runs on thecollection device 24 and provides three basic elements: one or morestructured collection procedures 70, data file 145, and one or morescripts. As the features of the structured collection procedure 70 anddata file 145 are the same as previously discussed above no furtherdetails is provided. The one or more scripts are small independentprograms that reside on the collection device 24 and each can perform aspecific set of tasks. Such scripts can include a protocol script 401, aparse script 403, and an analysis script 405 such as depicted by FIG.12, each of which are discussed in detail in the following paragraphs.

Protocol Script

The protocol script is a script that actually enables the execution ofthe collection procedure 70 by the processor 102 on the collectiondevice 45. At the time of initiation of collection procedure 70, theprotocol script in one embodiment causes the processor 102 to create adata structure that outlines the amount of data expected as outlined bythe collection procedure 70. In another embodiment, the data structurecan have a variable size, or be a fixed size but with a buffer e.g., anarray in the data structure, should additional data be collected duringthe collection procedure 70. For example, such have buffer can accountfor situations when the structured collection procedure 70 can beextend, if desired, or needs to be extended due to not meeting a desiredcondition, e.g., a patient biomarker value has not reached a desiredvalue, such as, for example, up to a maximum size of allocable memoryfor the data structure in memory 110 of the collection device 24. Thisdata structure, such as data file 145, stores at a minimum the time ofinitiation of the collection procedure 70, actual measurement ofbiomarkers, such as data event value 256, and time of the measurements,such as date-time stamp 169, and optionally all other information usedfor additional contextualization, such as the contextual information156, and request 240, such as meals, exercise, etc. As an alternativeembodiment, one can also consider the data structure to be a calendarthat is generated by the clinician 14 which can include details in termsof the day, and the time of day when a measurement needs to be made.This calendar feature also enables the patient to see readily when hehas to make the next measurement. The protocol script also causes theprocessor 102 to perform all of the functions necessary for theprocessor 102 to execute the collection procedure 70. Once appropriatedata is collected, e.g., a successful run of the collection procedure70, the protocol script causes the processor 102 to mark the datastructure with a completion flag 257 in one embodiment or provides it asstate condition of the software 34 in another embodiment and passescontrol of the processor 102 as provided in the software 34 to the parsescript. In the former embodiment, the completion flag 257 can also beused to provide information regarding the reason for ending/terminating,such as to identify the type of completion (end, logistical (timeout),adherence terminated, etc.). For the latter embodiment, as one or moreprocedures 70 may be loaded onto the collection device 24 at the factoryas mentioned previously above, providing state conditions for eachcollection procedure 70 in the software 34 helps to support therequirement that the procedure only be available after authorization bythe clinician 14. In one embodiment, such state conditions of eachcollection procedure 70 can be tracked by the software 34 and caninclude one or more of a ‘Dormant’ state, an ‘Authorized’ state, a‘Pending’ state, an ‘Active’ state, and a ‘Completed’ state. The Dormantstate is useful when the collection device 24 is shipped with one ormore embedded collection procedures 70, but until authorized for use,such as described above previously, cannot be use (or seen) by thepatient 12 on the collection device 24. In this case, the collectionprocedure 70 is said to be in a Dormant state. The Authorized state iswhen the collection procedure 70 becomes usable after the clinician 14authorizes it for use on the collection device 24. During this state,the collection procedure 70 can be configured (e.g., by the clinician)and initiated for start as also configured, e.g., via selection by theclinician, the patient 12, or by a start date. The Pending state is whena start date is set, but prior to execution, e.g., in which thecollection procedure 70 is waiting for some unknown time until the entrycriteria 226 is met before executing the schedule of events 222. Oncethe collection procedure 70 begins executing on or after the start date,via meeting the entry criteria 226 in one embodiment, the collectionprocedure is said to be in the Active state in which at least theschedule of events 222 is being implemented by the processor 102. TheCompleted state functions in a similar manner as to the completion flag257 when the collection procedure 70 has ended as mentioned abovepreviously.

Parse Script

The parse script is the script that causes the processor 102 to parsethe contextualized data, such as e.g., contextualized data 395 (FIG.11), once the collection procedure 70 data collection is complete. Theparse script causes the processor 102 to try to resolve any exceptions(e.g., in real time, i.e., as the procedure 70 is being executed) thatmay have arisen at the time of execution of the collection procedure 70,e.g., for only critical data events 237 in the collection procedure 70(e.g., a mandatory data collection for a biomarker value) in oneembodiment. If at the end of the execution of the parse scriptexceptions remain for at least the mandatory data required for thecollection procedure 70, then the parse script will cause the processor102 to signify that appropriate data has not been collected.Consequently, the collection procedure 70 is marked by the processor 102as incomplete via the completion flag 257 not being provided by theprocessor 102 in the data file 145. If there are no exceptions at theend of a parse script, e.g., at least for the critical events in oneembodiment, and/or for all events in still another embodiment, thecollection procedure 70 is marked complete via the processor 102providing the completion flag 257 in data file 145, which contains thecollected and contextualized data. The role of the parse script will beexplained hereafter subsequently in a still another embodimentillustrating an execution stage.

Analysis Script

The analysis script causes the processor 102 to analyze the completedcollection procedures 70 that have their own associated datasets, e.g.data file 145. The analysis performed by processor 102 according to theanalysis script can be simple (mean glucose value, glucose variability,etc.) or it can be more complex (insulin sensitivity, noise assessment,etc.). In one embodiment, the collection device 24 can perform theactual analysis itself, or the analysis can be carried out on acomputer, such as computer 18, 25. In one embodiment, the results fromthe analysis script can then be displayed either on the display 108 ofcollection device 24 by the processor 102 or on the display of aperipheral device. Reference to the scripts and program instructions ofthe software 34 are discussed hereafter with reference made to FIGS. 13and 14 as well as to FIGS. 2 and 5B.

Collection Procedure Execution

FIGS. 13 and 14 depict a collection procedure execution method 400performed by the processor according to the program instructions of thesoftware 34 using the above mentioned scripts during a collectionprocedure 70. The dash-dot lines indicate the boundary between thedifferent domains of the different scripts and are the boundaries acrosswhich exchange in control takes place. It is to be appreciated that thehereafter disclosed embodiments of the present invention can beimplemented on a blood glucose measuring device (such as a meter) thathas the capability to accept one or more structured collectionprocedures 70 and the associated meter-executable scripts discussedabove.

With reference first to FIG. 13, once a collection procedure 70 isinitiated on the collection device 24 by the processor 102 using theprotocol script 401 in step 402, such as in any of the above mannersdiscussed previously above in earlier sections, after meeting entrycriteria 226 (if provided in the collection procedure 70), a data eventinstance, e.g., an event 237, occurs according to the schedule of events222 in step 404. For the event 237, in this example, the processor 102prompts via a request 240 for the patient 12 to take a reading around alunch event as mandated by the collection procedure 70. For example, theprompting of the request 240 may be an alarm provided by the processor102 via indicator 148 that goes off, whereby the patient 12 is askedalso on the display 108 by the processor 102 to take a reading. In oneembodiment, the snooze feature as well as the skip reading feature areprovided by the software 34, where the patient 12 can use the userinterface 146 to enable a delay or to skip the data collection. Forexample, selecting the delay feature as discussed previously above inearlier sections can cause the processor 102 to prompt the patient 12again for the event 237 a predefine amount of time after enabling thedelay to the data collection. For example, such a feature could be usedin case the patient 12 cannot take the reading at the time of theprompting in one embodiment, e.g., at the beginning of the window oftime in which to provide the measurement/reading. Likewise, the skipfeature would be selected if the patient believes he/she cannot performthe measurement/reading within the window of time. An example of awindow of time or a specific time-window around an event is shown byFIG. 10B (“allowable window”).

The processor 102 according to the protocol script 401 then usesadherence criteria 224 in step 406 to determine whether the datacollection for the event 237 was successful by meeting the conditions ofthe adherence criteria 224 in one embodiment. For example, a successfuldata collection will occur if the patient 12 successfully collects thedata within the specified time-window. In another embodiment, the sameprocessing may be applied to one or more sampling group 262.Successfully collected data for such events in the schedule of events222 and/or sampling grouping 262 is then contextualized by processor 102according to the protocol script 401 in step 410, for example, byassociating in the data file 145 with the collected data, e.g., data256, the current time e.g., the date-time stamp 169 (FIG. 4), the event239 and/or request 240, and available contextual information 156, e.g.,about the patient's therapy as well as the unique identifier 167, ifneeded, as discussed also previously above in earlier sections.

If, in the above example, the patient 12 fails to collect data withinthe specified time-window, then in step 412 the processor 102 accordingto the protocol script 401 scans the contextualized data resident on thecollection device 24 to determine if a similar data-point is availablethat meets the requirements of the missed data-point. This data-pointwill be selected by the processor 102 according to the protocol script401 in step 414 only if it fulfils all requirements of the data-pointintended to be collected.

As an example, if the collection procedure 70 requires a pairedmeasurement, i.e., pre- and post-meal measurements, then it is importantfor both of these measurements to be made around the same event. In thiscase, substitution of any one value from a prior value is notpermissible; should such occur, an exception is marked for the eventunder consideration. In this scenario, the pertinent element in thedata-structure is incomplete at that location wherein the processor 102in step 416 will declare an exception, such as providing a <null> valueto the unique identifier 167 in the specific data record 152 for theevent 237 which caused the exception. Should no such constraint exist,then a data-point from the data resident on the collection device 24 canbe selected by the processor 102 in step 414 and added to thecontextualize collected data in step 410. This substitute data-pointwill have the same contextual information, event context, and collectedwithin a specified time-window of the original collection period if suchis a requirement. In step 418, according to the protocol script 401, theprocessor 102 will check to see data collection is completed for all ofthe events 237 in the schedule of events 222 of the collectionprocedure. The processor 102 also checks whether exit criteria 228 ismet, if such is provided by the collection procedure 70. If not, thenthe processor 102 proceeds with the next event in the schedule of events222 by returning to step 404 wherein the data collection then proceedsfor the remainder of the collection procedure 70 in a similar fashion.It is to be appreciated that frequent messages as part of the guidance230 of the collection procedure 70 can be displayed by the processor 102to the patient 12 on the display 108 to guide the patient throughout theentire data collection. It is to be appreciated that as part of theprotocol script that whenever any specified exit criteria is met, theprocessor 102 can end the collection procedure 70 in one embodiment orpresent as an option on the display 108 for the patient to select endingthe procedure 70 in another embodiment. Once the data collection iscompleted in step 418, the protocol script 401 then hands over controlof the processor 102 to the parse script 403 in step 420.

With reference to FIG. 14, which highlights the role played by the parsescript 403, when control is passed upon completion of the collectionprocedure 70, the parse script 403 checks the contextualized data 170 inthe data file 145 for incompleteness. To accomplish this, the processor102 reads the contextualized data 170 from memory 110 in step 422 andlooks for any exceptions (e.g., <null> value for any unique identifier167) provided in the data file 145 as an exception check in step 424according to the parse script 403. When possible, the processor 102tries to address any these exceptions using data available on thecollection device 24 should it be possible in step 426. As an example,applicable data either may be available from non-collection procedureevents or from data collected as part of another collection procedure70. If the exception cannot be addressed from existing data, then instep 428 the collection procedure 70 is marked incomplete. At this pointthe completion flag 257 for the collection procedure 70 is set asincomplete (e.g., not set, <null>, a pre-define value, etc.). Otherwise,if there are no exceptions and/or all exceptions have been addressed instep 426, then the processor 102 sets the completion flag 257 ascompleted and then can display the result of the collection procedure 70in step 430. The processor 102 in accordance with the parse script 403then collects all of the data associated with the collection procedure70 (i.e., data file 145) and hands control over to the analysis script405 in step 432.

In step 434, the analysis script will cause the processor 102 to performall the necessary analysis, such as analysis 258 (FIG. 6B) that isdetailed in the collection procedures 70, on the data collected in step432, if the completion flag 257 is marked complete in the data file 145.In one embodiment, simple analysis routines calculations can beperformed on the collection device 24, whereas more complex collectionprocedures 70, the analysis can be done on a computer, such as computer18 or 25.

When a collection device 24 containing one or more collection procedures70 is connected to a device reader 22, such as the Smart-Pix device,that is connected to computer 18 or the clinician computer 25, thesoftware 32 cause the associate processor to display automatically alist of the completed collection procedures 70 and their associated datafiles 145.

In one embodiment, the software 34 can interact with the device reader22, such as provided as a SmartPix device, for visualization of results,or with any other device including computer 18, 25, etc., that candisplay the results of the analysis of the data from the collectionprocedure 70. At this point, if on the clinician computer 25, theclinician 14 can decide to view the results of completed and analyzedcollection procedures 70 or carry out analysis of completed collectionprocedures 70. The clinician 14 can also review any collection procedure70 that did not complete and try to evaluate the exceptions that existin the collection procedure 70. This interaction gives the clinician 14an opportunity to give the patient feedback on his data and/or evaluatereasons for the failure to complete existing collection procedure(s) 70.

Use Case Example

Referring to FIG. 15, a use case example is provided which highlights asequence of actions carried out by the clinician 14 as well as thepatient 12. This sequence encompasses an overview of the clinician14-patient 12 interaction from the formulation of the medical questionto the completion of the collection procedure 70. The dash-dot lineindicates the boundary between the clinician 14 and patient 12 domainsand it is the boundary across which information exchange takes place.The discussion on the completed collection procedure 70 also serves toencourage the patient and provides the clinician 14 with an opportunityto provide feedback on patient performance and progress.

In step 440, patient visits the clinician 14 and in step 442, theclinician identifies a problem, which results in the selection ofmedical use case (medical question) in step 444. After selecting themedical question, such as on computer 25, the clinician uses thecomputer to select and define/customize the structured collectionprocedure 70 in step 446 using method 200 and/or 300 (FIGS. 5A and 7A).After prescribing the structured collection procedure 70, the computer25 provides the structured collection procedure 70 to the collectiondevice 24, which is received in step 448. The patient 12 starts the datacollection according to the structured collection procedure 70 using thecollection device 24 after satisfying the entry criteria 226 provided inthe procedure 70 in step 450. During the data collection in step 452,events 237 are automatically scheduled by the collection device 24 inaccordance with the scheduled of events 222 contained in the structuredcollection procedure 70. Adherence criteria 224 is applied to at leastto all biomarker measurements, which are evaluated and recorded formeeting the adherence criteria automatically by the collection device24. In step 454, the structured collection procedure 70 is completedonce the exit criteria 228 is met. Next in step 456, any availablecollection device based analysis 258 may be performed by the patient 12if desire. Next in step 458, a report may also be generated, such as thedata report mentioned in step 434 (FIG. 14). In step 460, the data(e.g., the complete data file 145) either from the collection device 24or from the patient computer 18 is preferably sent to the cliniciancomputer 25. The collected data is received in step 460, is thenanalyzed in step 462. Next, in step 464 a report can be generated, whichmay be used to facilitated a discussion of any additional results instep 466 with the patient 12. Next, documentation is printed in step468, which can be given to the patient 12 in step 470 as well asrecorded (stored) in an electronic medical record of the patient 12 instep 472. Various embodiments related to status reporting are discussedin later sections.

Generation, Modification, and Transfer of Collection Procedures

Embodiments of the present invention also enable the generation,modification, and transfer of collection procedures 70 to and from astructured testing enabled device, such as collection device 24. As thecollection procedures 70 stem from and aim to address specific medicaluse cases or questions, the transfer of the resultant information e.g.,data file 145, from one device to another is carried out in a securemanner. Additionally, a method whereby all of the collection procedurerelated information (e.g., data file 145) for a patient or a group ofpatients can be managed in a secure and efficient manner.

It is to be appreciated that the discussion provided hereafter includesaspects related to the interaction between the clinician 14 and thepatient 12 as discussed previously above concerning FIG. 15. Inparticular, the disclosure hereafter provides details regarding theinfrastructure required to manage the generation, transfer, and analysisof the collection procedures 70. Reference hereafter is also made to thesystem 41 of FIG. 2, as aspects pertaining to the transfer of devicesand information (data, reports, etc.) to and from the devices 18, 25 and52 are provided.

In one illustrated embodiment, the system 41 can comprise server 52being a web-server that serves as a repository of a plurality ofcollection procedures 70 a, 70 b, 70 c, 70 d, as software 34 thatresides on the clinician computer 25, and the collection device 24, suchas provided as a blood glucose meter. Henceforth these components arereferred to as the “server”, “software”, and the “meter” respectively.Additionally, the computer 25 where the software 34 resides is termed asthe “client”.

In one embodiment, the server 52 can serve as a central repository for anumber of collection procedures 70 a, 70 b, 70 c, and 70 d that addressspecific medical questions. Accordingly, one or more collectionprocedures 70 can be downloaded from the server 52 to the cliniciancomputer 25. In such an embodiment, all communications between theserver 52 and the client computer 25 is done in a secure and web-basedformat. Additionally, in another embodiment, there is no full two-waydata transfer between the computer 25 and the server 52 such thatpatient data can never be transferred to the server 52. Furthermore, inother embodiment, a request for a collection procedure from the server52 can be made only with a valid identifier. Such an embodiment ensuresthat only authorized clients are allowed to access the server 52 todownload the requested collection procedure(s) 70.

In one embodiment, each collection procedure 70 downloaded from theserver 52 can be used only once (e.g., if the completed flag or state isset, the procedure 70 cannot be run again until reauthorized by theclinician 14). Each successive download of the collection procedure 70requires access from an authorized client user with a valid ID 71 (FIG.2). The server 52 also provides the client computer 25 with updatesthereby ensuring that the software is the most recent version. Therealso exist restrictions on the communication from the client computer 25to the server 52. The server 52 can only access information related tothe installed version of the software 34. It is not possible for theserver 52 to access any data resident in the client database e.g.,memory 78. Additionally, the data on the client computer 25 is accesscontrolled so that it cannot be used and accessed without the necessarypermissions.

The software 34 residing on the client computer 25 serves as theinterface between the server 52 and the meter 24. The software 34 at thefront end includes a user-friendly interface that provides the clinician14 with ready information pertaining to the overall practice. Thisinformation may include details about all assigned patients, detailsabout the patients the clinician 14 is scheduled to see on a given day,as well as the details about patients that need extra attention. Thesoftware 34 also interfaces with a database that includes relevantpatient data that is arranged by an individual patient ID, such as usedby and provided in the healthcare record system 27. The softwareinterface also allows the clinician 14 to access the patient 12 detailsusing the patient identifier. In this manner the software 34 providesthe clinician 14 with information about the collection procedure(s) 70that the patient 12 has already completed (i.e., those with a completedset for the completion flag 257), the associated results, and also thecollection procedure(s) 70 that the patient 12 is currently performing.All of the data residing on the client computer 25 is secure andaccess-controlled. The server 52 has no means to access the data. Theclinician 14 can access data from all patients in the practice. Inaddition, an individual patient 12 can access his data, such as from aserver of the clinicians, using his patient identifier in a secureweb-based format. This data is downloaded to the database on computer 25from the meter 24 and associated to the patient 12 using the patientidentifier.

At the time of data download from the meter 24, the software 34 alsoperforms an analysis on the data to ensure that the integrity of thedata is maintained and no corruption in the data has taken place at thetime of transfer. The client computer 25 with the help of the software34 can also send emails to the individual patients and these emails cancontain information about an upcoming appointment, reminders on what thepatient is supposed to do after an appointment and reports that areresults of a completed collection procedure 70. When the clinician 14downloads a collection procedure 70 from the server 52 for a particularpatient, the collection procedure 70 is associated with the patientidentifier. In this way, it is possible to account for what collectionprocedures 70 are currently underway for his patients.

A downloaded collection procedure 70 can also be modified by theclinician 14 using the software 34 to tailor the collection procedure 70to individual patient needs as previously discussed above in earliersections (FIG. 7B). At the time of modification of the collectionprocedure 70, the clinician 14 also has the option to alter the analysisthat will be carried out on the modified collection procedure 70.Additionally, even for standard collection procedures 70 that have notbeen modified, the clinician 14 has the option to add additional optionsfor analysis.

Furthermore, the clinician 14 can decide and set guidelines as to whenthe procedure 70 must terminate. For example, the clinician 14, candecide and set how many adherence violations are allowed, i.e., how manymeasurements can the patient miss, such as via using the optionsparameter 232 in the collection procedure 70.

Once a collection procedure 70 is introduced into the meter 24 by theclinician 14 (details discussed in the next section), the collectionprocedure 70 cannot be altered by the patient 12 (i.e., only by anauthorized user with edit rights, which is typically only the clinician14). Additionally, the collection procedure 70 is associated with boththe clinician 14 (the prescriber) and the patient identifiers to ensureaccounting of the collection procedure 70 and associated data (e.g.,data file 145).

The software 34 also allows the clinician 14 to select the type ofreport that will be generated once the completed collection procedure 70has been analyzed. This report is tailored for the device on which itwill be viewed. The report could be for a mobile device such as atelephone, a palm device or a meter, or a computer, or a printed format.The software 34 also has the ability to connect with an electronicmedical records system to add patient data and results of analysisperformed on the data from a collection procedure 70 to the medicalrecords.

The meter 24 serves as the mechanism by which prospective andcontextualized data is collected by the patient 12 as recommended by thecollection procedure 70. The meter 24 can be owned by the patient or itcan be owned by the clinician 14 and loaned to the patient 12 for theduration of the data collection associated with the collection procedure70. The clinician 14 can introduce the collection procedure 70 into themeter 24 by a number of mechanisms. For example, the collectionprocedure 70 can be downloaded from the server 52 and added to the meter24 via a connecting cable that links the client computer 25 to the meter24 in one embodiment. The collection procedure 70 can also be obtainedin another embodiment on a chip (e.g., computer readable medium 40) thatcan be inserted into the meter 24. This collection procedure 70 is thenloaded into firmware of the meter 24 where it can be initiated by thepatient 12. The collection procedure 70 can also be introduced using anRFID tagged chip (e.g., computer readable medium) in still anotherembodiment.

Along with the downloaded collection procedure 70, the meter 24 also hasthe ability to display instructions to the patient 12 that guide thepatient at the time of data collection. Additionally, as discussedabove, the collection procedure 70 can introduce into the meter 24 boththe patient identifiers as well as the clinician identifier. Similarly,the data collected from the meter 24 can be associated with the patientidentifier and clinician identifier, such as part of setup data 163(FIG. 4) in the data file 145. Additionally, the setup data 163 in thedata file 145 can include information about the meter 24 (i.e.,measurement noise, calibration data), as well as strip lot numbers andother information about the strips used for any data collection event237. Such information may be helpful at the time of data analysis.

At the completion of the collection procedure 70 the meter 24 can beconnected to the software 34. At that time data, such as data file 145,is transferred securely and stored by the processor 76 of the clientcomputer 25 according to the software 34 running thereon. Once theanalysis performed on the data from the collection procedure iscompleted by the software 34 on the client computer 25, the meter 25also has the ability to store results of the analysis for patientreference. Reference is now made to FIGS. 16-18 hereafter.

Software GUI

In one embodiment, a typical workflow highlighting further features ofthe software 34 useable through a graphical user interface (GUI 500)provided thereby on a computer, such as computer 25 and/or server 52,are presented. In this example, the typical scenario is when theclinician 14 opens the case file for a particular patient is considered.As shown in FIG. 16, the clinician 14 can readily visualize importantdetails about a displayed patient file 502 using the GUI 500 of thesoftware 34 running on the client computer 25. On a top pane 502 of theGUI 500, the clinician 14 can see and use various administrative tasks504, such as changing the displayed patient file, create an emailcontaining information form the patient file, create a fax containinginformation from the patient file, save the patient file, bookmarkingdata in the patient file, select existing bookmarks, printinformation/graphs from the patient file, etc.

On a left pane 506 of the GUI 500, the clinician 14 has additionaloptions 508 such as the option to download patient data, such as datafile 145, when a meter 24 is connected to the computer 25 or 18 (wiredor wirelessly). The other options 508 also can also include viewingdetails regarding a patient profile, logbook, and additional records,and graphs based on calculated data, etc. As indicated by FIG. 16, thesummary option is selected, which shows its content in a main pane 510.

The main pane 510 indicates all of the typical steps in a workflow fortherapy administration for the patient 12. These steps can include thefollowing: Disease State 512, Therapy Selection 514, TherapyInitialization 516, Therapy Optimization 518, and Therapy Monitoring520. Each step provided as an icon on the GUI 500 is discussedhereafter.

Disease State 512 is a determination of the disease state, e.g., thepatient is a Type 1 or a Type 2 diabetic. Typically, the disease statedetermination is carried out when the patient 12 first visits theclinician 14 or when the clinician 14 suspects that a particular patientmight be at risk. Therapy Selection 514 follows thereafter once thedisease state is determined, and the clinician 14 needs to select anappropriate therapy that takes into account the patient's disease state.As Therapy selection 514 can include the processes of methods 200 and300 shown by FIGS. 5A and 7A, respectively, no further discussion isprovided. Therapy Initialization 516 is the process of therapyinitialization involves establishing the initial details by means ofwhich therapy is administered to the patient 12. This may includedetails about the starting dose of the therapy, time when thetherapeutic is taken, and the likes. Further details about TherapyInitialization 516 are provided hereafter in reference to FIG. 17.Therapy Optimization 518 involves the determination of the besteffective dose for the patient such that it will not cause side effects.An example of a method for therapy optimization is disclosed by U.S.patent application Ser. No. 12/643,338 “STRUCTURED TESTING METHOD FORDIAGNOSTIC OR THERAPY SUPPORT OF A PATIENT WITH A CHRONIC DISEASE ANDDEVICES THEREOF” filed Dec. 21, 2009, and assigned to Roche DiagnosticsOperations, Inc., which is hereby incorporated by reference. Finally,Therapy Monitoring 520 involves routinely monitoring the patient 12 todetect therapy obsolescence after the selected therapy has beenoptimized. Thus, the GUI 500 provides the clinician 14 with all of theuseful information in a user-friendly format.

FIG. 17 represents the scenario when the clinician 14 has alreadydetermined the disease state and selected a therapy, via Disease State512 and Therapy Selection 514, and is at the step for TherapyInitialization 516. As shown, the software 34 shades in the GUI 500 thesteps already completed wherein only the step currently underway, e.g.,Therapy Initialization 516, is highlighted. In addition, in oneembodiment, the software 34 does not permit the clinician 14 to progressto the next step without accomplishing all the required actions in thecurrent step (in other words, all previous steps have beenaccomplished). However, the software 34 provides the clinician 14 withthe option to go back and modify prior steps via selecting theparticular icon for the step in the GUI 500.

In this example, the patient 12 is diabetic, and currently for TherapyInitialization 516 the clinician 14 needs to initialize a long actinginsulin therapy for a Type 1 diabetic patient. As shown, the clinician14 is presented on the GUI 500 for this step with all availableinitializing options 522 for initializing the therapy. For example andas shown, the clinician 14 can select a type of drug 524, such as showas a long acting basal insulin, and select procedure selection icons 526associated with the drug 524 and each associated with a collectionprocedure 70 that is available for addressing a therapy question(s)regarding a particular drug (e.g., Lantus, Levemir) listed associated(and available) with the type of drug 524. The software 34 through theGUI 500 also permits the clinician 14 to decide if additional therapyrelated parameters 528, such as insulin sensitivity, insulin tocarbohydrate ratio, and the like, should be undertaken if such isneeded. Additionally, further details for the therapy initialization canbe viewed via selecting an icon for general information 530.

When the clinician selects one of the procedure selection icons 526, thesoftware 34 provides a snapshot 532 of the conditions set in theassociated collection procedure 70, such as illustrated by FIG. 18.Typical initial conditions provided in the snapshot 532 can include:frequency of dosage (dosing adjustment), (default) starting dose, targetlevels, schedule of events (e.g., Measure fasting blood glucose for 3days), recommendations for computation (e.g., modify drug dose base onthe 3-day median, measure remaining for days to assess the effect), andthe like. If more details regarding the selected collection procedure 70is desire, such as related medical literature, case studies that mayhave formed the basis for the structured collection procedure, and thelike, can be viewed via More Detail icon 534. The clinician 14 has alsothe choice to either accept the collection procedure 70 as provided, viathe Accept icon 536 or suggest modifications to the collection procedure70 via the Modify protocol 538. As selecting the Modify protocol 538 canopen on the GUI 500, for example, a screen representation of all theparameters in the procedure 70 for modification, such as depicted byFIG. 7B, and as such was previously discussed above in earlier sectionsno further discussion is provided. Once modifications are made to thecollection procedure 70, the clinician 14 can review and accept thechanges. Upon accepting the collection procedure 70, via selecting theAccept icon 536 on the GUI 500, the software 34 cause the processore.g., processor 76, to send the completed collection procedure 70 to themeter 24 as discussed previously above in earlier sections. Certainadvantages of the above mentioned embodiments of the present inventionare noted hereafter.

Although not limited thereto, the embodiments of the present methodoffer the following noted advantages. Certain embodiments enablecontextualization of collected data by taking into account factors suchas meals and existing medications. All of the data analysis can becarried out on prospective data, i.e., contextualized data collection iscarried out keeping in mind the medical question that needs to beaddressed. The collection procedures 70 are each geared towardscollecting bG data to address a specific medical issue, e.g., control ofpostprandial glycemic excursions, regulating the fasting blood glucosevalue, characterizing the patient insulin sensitivity, monitoring thepatient's therapeutic response, and the like. Using such collectionprocedures, makes the task of collecting BG values goal oriented as thepatient knows the reason why he or she is carrying out such tests. It isbelieved that awareness of the reason for conducting tests would lead toan increase in adherence.

Also, certain embodiments provides the infrastructure necessary tomanage multiple simultaneously running collection procedures 70 ondifferent collection device 24 by different patients 12, while ensuringsecure web-based communication for receiving and transmitting thecollection procedures 70 and the results obtained from the analysis ofthese collection procedures 70. For example, certain embodiments helpthe clinician 14 by: making it easier for the clinician 14 to impact allof the stages of a patient's therapy ranging from disease statedetermination to regular monitoring under a working regular therapy;making it possible for the clinician 14 to manage the various stages ofcollection procedure 70 execution for a group of patients in a secure,and web-based format; offering the clinician 14 flexibility by providingthe option to select collection procedures 70 from a pre-determined listor modify a collection procedure 70 based on patient needs; making theinteraction between the clinician 14 and the patient 12 more effectiveas the communication is entirely data-centric and guided by, forexample, a medical question at hand.

Status Reporting

Status reporting can be provided in many forms. For example, in certainstructured collection procedure embodiments, information indicating atwhat stage of protocol execution that a patient is in can be provided.For example, as depicted by FIG. 19A, a display 106 of device 24 canprovide information e.g., such as in the form of a displayed electronicmessage 590, regarding that event 237 n (where n is a, b, c, . . . )(FIG. 6B) of the collection procedure 70 has been successfully completedand that the next event is event 237 n+1. Additionally, results at theend of execution of the collection procedure 70 can be provided to thepatient in still other embodiments as part of a results message 592 ofthe status reporting, e.g., recommendations 260 (FIG. 6B), as depictedby FIG. 19B. In still other embodiments, a number of different reportscan be electronically displayed, such as via display 106 of device 24,as a report list 594, e.g., Report A, Report B, Report C, etc., fromwhich a patient can select a desired report via the user interface 146from the list at the conclusion of a structured collection procedure 70as depicted by FIG. 19C. In such an embodiment, for example, one reportcan be a tabular or a graphical representation of the outcome of thecollection procedure, e.g., recommendation 260, another report can be atabular or graphical representation of how well the collection procedurewas followed, and still another report can be a tabular or graphicalrepresentation of performance on different aspects of the collectionprocedure to serve as a guide for selecting future collection proceduresor identifying areas where additional user support may be needed. Stillother types of report may include: providing the number of adherenceelements; providing the average glucose readings in fasting and inpost-prandial periods; and providing the differences in bG in week andweekend periods. In still other embodiments, the functions of saving andprinting 596, 598 a selected report can also be provided on the display106 by the device 24 as well as transmitted to a designated health careprovider (e.g. clinician 14) via a send function 599 as also depicted inFIG. 19C. In such an embodiment, the health care provider can bedesignated in memory 110 of the device 24 such as by an email addressand/or IP address, such as of a server, computer, and/or computingdevice of the health care provider, to which the selected report issent, e.g. over network 50. In still other embodiments, the patient 12could be exposed to “partial” reporting of on-going results inanticipation of the reporting they would receive upon completion of thestructured collection procedure. Such a feature can also be implementedvia the report list 594. In further embodiments, such status reportingcan be displayed on a number of different devices, such as the devicereader 22, or with any other device including computer 18, 25, etc.,that can display such status reporting of the collection procedure 70.

In still other structured collection procedure embodiments, at eachaspect of running the collection procedure 70, right from initializationto the end of the execution, some sort of status reporting can beprovided in which to aid the patient in executing and completing thestructured collection procedure. The types of status reports which canbe provided at each of the various aspects of execution of thestructured collection procedure 70 is discuss hereafter with referencemade to FIG. 20, which depicts a method for performing a structuredcollection procedure according to another embodiment of the presentinvention. It is to be appreciated that process steps shown in FIG. 20having like numbering of process steps discussed in proceeding sectionshave like function, and thus no further discussion is provided forbrevity.

Start of the Structured Collection Procedure.

In one embodiment, starting information 600 can be provided before thepatient 12 initiates the structured collection procedure 70, or inanother embodiment as part of the procedure start in process step 316.The starting information 600 in one embodiment conveys to the patient 12the reason(s) why the structured collection procedure should be carriedout and also what results can be expected upon successful completion ofthe collection procedure 70. In other embodiments, the startinginformation 600 can include information regarding the entry criteria 226that needs to be met in order to start the collection procedure 70 inprocess step 318. Additionally, general suggestions regarding therequirements for the adherence criteria 224, e.g., explaining whatconstitutes a measurement that cannot be used, e.g., not fasting, therequisite time before a fasting reading, etc., as well as encouragement,e.g., “The better the adherence, the better the results as well as thequicker the overall task will be completed,” can be provided in stillother embodiments of the starting information 600. In still otherembodiments, specific information for the clinician 14 can also beincluded in the starting information 600, e.g., the intended user groupsfor the collection procedure 70, the burden of the collection procedure70, and the likes. It is to be appreciated that such startinginformation 600 can be given as a printed report, can be made availablein a secure fashion over the web so that it can be viewed on a computer,such as computer 18, 25 (FIG. 1), and/or displayed on the display 106 ofthe device 24, or on a display of any other appropriate handheld device.In still other embodiments, the starting information 600 is included aspart of the guidance 230 (FIG. 21) provided by the structured collectionprocedure 70 at startup and/or can be pre-defined in the collectionprocedure 70 and customized by the clinician 14 as desired.

In still other embodiments, the starting information 600 can provide theanticipated total amount of time required to complete the collectionprocedure and the number of expected measurements. An example of suchinformation provided by the starting information 600 for the total timeand measurements may be a message which states “The anticipated amounttime is about 4 weeks to complete the collection procedure whichrequires 30 fasting pre-breakfast measurements.” It is to be appreciatedthat starting information 600 can be delivered in a number of differentways, in addition to the above mentioned means. For example, a calendareither printed, electronically provided on computer 18, via the web,and/or on device 24 as depicted by FIG. 19D (i.e., electronic calendar602) can be provided which contains the days and times at which ameasurement is to be made for performing the associated collectionprocedure 70.

During the Collection Procedure Execution

While the structured collection procedure 70 is being executed, forexample, on the device 24, there are a number of indicators that can beprovided to the patient 12 as status updates. These indicators help thepatient 12 to know how he/she is performing in the execution of thecollection procedure 70 and are also useful in providing guidance underspecial or adverse conditions that the patient 12 might encounter. Suchstatus indicators include, but not limited thereto, the followingexamples.

Initially, and as stated above in a previous section, the structuredcollection procedure 70 may end if in step 318, the entry criteria 226is also not met. If the entry criteria 226 is not met in step 226, thenin this alternative embodiment a message 601 may be provided whichnotifies the patient 12 of such a fact and which requests in step 607whether to re-start the procedure by providing the starting information600 again. Additionally, during the collection procedure execution, thedisplay 106 of the device 24 can provide a status indicator 604 (FIGS.19E) which indicates how far along the patient 12 is and how far alonghe/she has to go in completing the collection procedure 70 that isrunning on the device. In one embodiment, such a status indicator 604can be provided as a needle 603 in a gas gauge 604A as depicted by FIG.19E, where empty represents the start of the collection procedure 70 andfull represents the end of the collection procedure 70. In anotherembodiment, the status indicator 604 is provided as a progress bar 604Bas depicted by FIG. 19F, where a bar 605 progresses from 0% completed onone side of the indicator towards 100% completed on the other side ofthe indicator. In one embodiment, the value indicated by the either theneedle 603 of the gas gage 604A or the bar 605 of the progress bar 604B,can be based on the number of successfully collected measurements (i.e.,collected according to a scheduled event 237 and which met the adherencecriteria 224 in step 322) divided by the total number of suchsuccessfully collected measurements needed (i.e., to satisfied the exitcriteria 228) and displayed as either a fraction (FIG. 19E) or as apercentage (FIG. 19F). In particular, the processor 102 can show suchprogress of the structured collection procedure 70 by counting thenumber of unique identifiers associated with the collected patientstored in memory 110, (i.e., the data file 145) and counting the numberof events 237 in the schedule of events 222 which have assignedadherence criteria 224 multiplied by any days requirement provided bythe exit criteria 228 (e.g., 3 days for the collection proceduredepicted by FIG. 21). Other examples of what values on which tobase/measure such progress can include, and not limited thereto, onattaining a specified bG value as well as on additional criteria when avalue crosses a threshold value. In other embodiments, progress can bemeasured by: indicating the percent (%) attainment of a goal, such as atitration of a medication till a diagnostic measurement range isattained; by showing a comparison to a population of many such patienttitrations; and via a characteristic “Rate of Change of Medication” to“Remaining Duration” function to predict the remaining duration for thecurrent user. It is to be appreciated that showing such progress whichdescribes how long it would take to complete the collection procedure 70can differ based on whether the collection procedure is a fixed scheduleassessment or a variable schedule assessment/optimization, which maytake an unknown amount of time to complete. For example, collectionprocedures providing fixed schedule assessments, such progress can bemeasured either by the amount of time that remains, or by the amount ofevents that remain. For example, such progress could be shown by asimple countdown e.g., as a graphically displayed message “You have xdays, and y measurements until completion,” provided on display 106 oras part of the information displayed in the electronic calendar 602(FIG. 19D). For collection procedures providing variable scheduleassessments/optimizations, for example, the measure for completion canbegin through a default number based on clinical data, either providedby the clinician 14, the clinician computer 25, and/or a server 52, suchas of manufacturer 64. In such an embodiment, the trajectory of thepatient 12 towards completion of the collection procedure 70 wouldinitially be assumed to be coincident with a predicted trajectory thatcan be based on a median or a mean value of individuals (either similarindividuals, or all individuals from a population source) who havecompleted the same procedure. As data from the patient is collected bythe device 24, the patient's trajectory can be overlaid on the predictedtrajectory (e.g., provided as part of the setup data 163 for thecollection procedure 70) by the processor 102. As long as the patient'strajectory is overlaying within a predetermined variance based model,the predicted duration remains the same. However, if the actualtrajectory varies by more than a predetermined value, e.g., a cubicspline, or the likes (e.g., also provided as part of the setup data 163for the collection procedure 70), can be used to extrapolate the newlyestimated end point, and thereby the microprocessor of the device 24 candynamically adjust the projected completion of the collection procedureby the patient 12, and displayed accordingly. It is to be appreciatedthat for each type of collection procedure, there may be differentpredicted trajectories. In still other embodiments, motivationalencouragement messages 606 may also be provided with each statusindicator 604 such as, for example, a suggested adherence change whichmay increase the rate of progress in completing the running collectionprocedure 70. For example, if the processor 102 notes in the data thatthe patient 12 has stalled on one phase of an optimization basedcollection procedure 70 because the patient have not been in a neededfasting state at a certain measurement time (via, e.g., either the entrycriteria 226 in step 318 or the adherence criteria 224 in step 322 beingnot met), the device 24 can encourage them to complete this importantstep and provide guidance to do so, e.g., providing a message that asksthe patient to starting in 60 minutes to only have water till the timeof the fasting measurement. This way an alert is given for the lastchance to eat and the alert is given enough in advance that the user canact on it.

In still other embodiments, the patient 12 can be given feedback on theextent of his or her adherence to the collection procedure 70. As shownby FIG. 20, in this alternative embodiment, if after process step 322the adherence criteria 224 is not met, then in process step 610 thedevice 24 checks to see if a violation occurred (i.e., failure by thepatient to execute an particular event 237). An example of a violationfor a particular event 237 may be, for example, failing to take arequired measurement within a required testing window, failing to eat aparticular meal type and/or size, not fasting, not entering requesteddata, not performing a requested action, and the likes. For each event237, a check for a violation can be programmed into the collectionprocedure 70 (e.g., pre-defined and customizable by the clinician), suchas by indicating either Yes or No in each violation parameter 609 of thecollection procedure 70 as depicted by FIG. 21.

In this illustrated embodiment, selecting a yes “Y” in the violationparameter 609 indicates to the processor 102 that failing thecondition(s) of the associated adherence criteria 224 will cause aviolation during the process step 610. If no such pre-defined violationoccurred, i.e., the violation parameter 609 is set to no “N”, then theprocess continues with evaluating the exit criteria 228 in process step326 (FIG. 20) as disclosed above in reference to FIG. 8A in a previoussection. If, however, the violation parameter 609 is set to yes “Y”,then in step 610 the processor will send automatically a violationmessage 640 to indicate that an adherence violation has occurred. In oneembodiment, the device 24 will send automatically, via communicationinterface 124, the violation message 640 to the clinician. Such aviolation message 640 can be simply a notice letting the clinician knowthat the patient had a violation, and/or in another embodiment a requestto contact the patient due to the adherence violation. In anotherembodiment, the violation message 640 may be provided by the processor102 on the display to notify the patient 12 that a violation hasoccurred. In another embodiment, the violation message 640 can be aprediction as to what is likely to happen if the patient 12 continuesnot to met the adherence criteria, such as e.g., “You are gainingweight”; “Your therapy will not be efficient”, and the like. It is to beappreciated further that when a violation occurs, the processor 102 canalso record the occurrence of the violation in an embodiment of the datafile 145 in a violation field 611 for the associated event 237 asdepicted by FIG. 4.

As also depicted by FIG. 4, type codes 613 may be provided in theviolation field 611 by the processor 102 to indicate what caused theviolation (e.g., “A” measurement taken before window, “B” measurementtaken after window, “C” measurement skipped, “D” an incorrect amount ofa requested medication is taken, “E” a requested medication is nottaken, “F” medication taken at incorrect time (e.g., incorrect pre- orpost-prandial time), etc.) to provide context to the violation. Forexample, event 237 d, which did not received a unique identifier 167 dueto failing the adherence 224, was a measurement which could cause aviolation (i.e., violation parameter 609 set to yes “Y” in thecollection procedure 70 for the associated event 237), and thus caused aviolation from being skipped. As such the processor 102 recorded a “C”type code 613 in the violation field 611. Such context is informationthat the clinician can use in assessing how the collection procedure 70may be adjusted to better suit the patient 12 in the future.

With reference made back to FIG. 20, next in one embodiment, in step612, a violation counter is incremented in process step 612, and inprocess step 614, the number of violations (i.e., violation counter) ischecked to see if it exceeds a maximum number of violations permitted(i.e., violation number (VN)) before automatic termination of thecollection procedure 70 occurs for excess adherence violations. Theviolation number (VN(s)) 615 can be preset in the collection procedure70 as depicted by FIG. 21 and adjusted by the clinician as desired. Instill other embodiments, a number of violation numbers 615 could also beprovided in the collection procedure 70 wherein each violation numberwould be set for each of the Type Codes 613, such that if the violationcounter for each Type Code 613 exceeded the associated violation number,the collection procedure 70 would terminate due to that specific typeviolation. In still other embodiments, the violation number 615 couldrepresent the number of violations in a pre-defined period of timeinstead of an absolute number since the start of the collectionprocedure 70. For example, the pre-defined period time could be designedand adjusted by the clinician 14 in the collection procedure by a timeparameter (t) 619. For example, in one embodiment the processor 102 instep 612 would also check to see whether the violation counter exceededthe violation number 615 within the associated pre-defined period (t)619, or in another embodiment any of the violation numbers associatedwith each Type Code 613 within their associated pre-defined period (t)619. In the illustrated embodiment of FIG. 20, if the violation number(VN) 615 is exceeded in process step 614, i.e. the violation counter“Violations” is greater than the violation number (VN), then a failedmessage 617 is provided in process step 616 and the procedure ends inprocess step 328 as discussed previously above in an earlier section.The failed message 617 can be pre-defined in the collection procedure 70as depicted by the FIG. 21 and customized by the clinician 14 asdesired. The failed message 617 can be provided on the display 106 ofthe device 24 and/or to the clinician 14 via communication interface124.

In one embodiment, the patient 12 can be told how many further adherenceviolations he/she can have before he/she might be forced to quit thestructured collection procedure 70, such as part of the messages 606provided in the calendar embodiment (FIG. 19D). For example, the messagemay be “You have {Violation Counter} of {VN} permitted violations,” or“You have {VN-Violation Counter} permitted violation remaining,” where {} indicates the current parameter value. In still other embodiments,similar status indicators such as the gas gage 604A and the barindicator 604B can graphically convey such information. For example,FIG. 19G shows a gas gage 604C which indicates the number of adherenceviolations committed (e.g., the violation counter=2) and the maximumpermitted (i.e., Violation Number (VN)=3) before automatic terminationof the collection procedure 70 for excess adherence violations (i.e.,the violation counter “Violations” is greater than the violation number(VN) in process step 614). In still other embodiments, such informationcan be provided graphically by icons, and/or images which change to showa change in the violations remaining e.g., such as in video gamesshowing the number of lives remaining.

In other embodiments, after each violation which does not result intermination (e.g., Violation Count<VN in process step 614) or after aset number of such non-terminating violations (e.g., Violation Count=s,where s<VN), the device 24 can check to see if the user should bequeried, for example, in process step 618. In still other embodiments,process steps 612, 614, and 616 can be made optional and thus notprovided, and in still other embodiments process steps 610, 612, 614,and 616 can be made optional and thus not provided, wherein in suchembodiment, after not meeting the adherence criteria 224 in process step322, the device 24 then checks to see if the user should be queried inprocess step 618. If the result of process step 618 is no in the abovevarious embodiments, such as in the case where no query message(s) 621(FIG. 21) is defined in the structured collection procedure 70 or wherethe set number (s) 623 of such non-terminating violations has not bereached (e.g., Violation Count< >s), then the process proceeds toprocess step 326. If the result of the process step 618 is yes, then inprocess step 620 the query message 621 is provided to the patient 12 ondisplay 106 of the device 24. The query message 621 and set-number (s)623 can be pre-defined in the collection procedure 70 as depicted by theFIG. 21 and customized by the clinician 14 as desired.

For example, in one embodiment, the query message 621 may be a questionasking the user if he/she understands the structured collectionprocedure 70, which is asked after the second violation, i.e., s=2. Inother embodiments, other values for the set-number 623 may be used suchthat the query message 621 is asked after a particular number ofviolations have occurred, can be set to an “all” value in which aftereach violation the query message is asked, or to a <null> value in whichno query message 621 will be asked such that the processor 102 proceedswith process step 326.

In the illustrated embodiment depicted by FIG. 20, the user may answerthe query message 621 via selecting either a “yes” or “no”, e.g., viathe user interface 146 (FIG. 3). If “yes”, then the collection procedure70 would continue, such as at process step 326 (FIG. 20). If “no”, thenthe device 24 provides helping information 625 in process step 622. Suchhelping information 625 may include re-displaying the startinginformation 600 pertaining to purpose of the collection procedure 70 andthe requirements on how the collection procedure needs to be conducted.If after such information is displayed to the user e.g., on display 106,the device 24 in other embodiments can query the user further in processstep 624 via presenting another query message 621′. The query message621′ can be, e.g., a request to see if the patient may need feedbackfrom the clinician 14 to better understand why the violation occurred,to which the patient may answer yes or no via the user interface 146. If“no”, then the collection procedure 70 would continue, such as at step326, and if “yes”, the device 24 could then send a message 627 inprocess step 626, e.g. via communication interface 124, to the clinician14 to contact the patient due to an adherence violation. The querymessage 621′, the helping information 625, and the clinician message 627likewise can be pre-defined in the collection procedure 70 as depictedby the FIG. 21, and customized by the clinician 14 as desired.

In still other embodiments, in process step 618, the processor 102presents on the display 108 questions and answers, e.g., questionspresented with yes or no answers, in which to determine why theadherence criteria was not met. If in process step 618, use of thequestions and answers by the patient 12 (i.e., via entering answersusing the user interface 146) fails to provide a determination of whythe adherence criteria was not met, then the processor 102 displays amessage on the display to contact the clinician 14.

It is to be appreciated that the above mentioned type of querying in oneembodiment and/or presentation of questions and answers in anotherembodiment may help to get the patient 12 back on track with thecollection procedure 70 due to minor misunderstandings. In still anotherembodiments, the adherence violation in process step 628 results in atriage message 629 being sent automatically (e.g., from device 24 toclinician computer 25 via network 50) to the clinician 14 to help theclinician 14 identify which patients 12 are at risk of not completingthe structured collection procedure 70. Such messaging may prompt theclinician 14 to contact the patient 12 to provide information andfurther motivation.

In still other embodiments, the collection procedure 70 can providepossible ways to reduce the number of accumulated adherence violationsthrough closer adherence. For example, the clinician 14 may at somepoint during the collection procedure 70 reset the violation counterand/or change the violation number 615. In still other embodiments, thedevice 24 can provide a way the patient 12 earns adherence credits basedon a successfully completing a period of adherence that would cancelaccumulated violations, and/or to earn a reduction in the pendingviolations by opting into a form of the procedure that provides moreguidance on the aspects of the procedure that are the source of theviolations. In still another embodiment, the device 24 can permit apatient who is having problems with testing at the correct time, to optinto a version of the procedure 70 that provides more prompting with theupcoming test, such as a reminder at the time of the test and anothershortly before the end of the grace period for that test if it has notbeen performed. In still other embodiments, the number of accumulatedadherence violations can be reduced by providing reminders at mealtimeof taking post-prandial measurement, by indicating at measurement time,the time/details about next measurement, as well as by providingencouragement during protocol execution.

In still other embodiments, when an adherence violation occurs in aparticular portion of the collection procedure 70, the device 24 canrecommend that the user seeks help, such as to contact the clinician 14to gain possible insight or motivation, and/or can provide particularinformation on where to seek such help. For example, the clinician coulddesigned by the options parameter 232 for which particular events 237such information is to be provided if a violation occurs. For such anembodiment, the processor 102 in process step 630 then checks to seewhether such a designation has been made in the collection procedure 70via help flag “*” being provided in the options parameter 232 for theevent 237, e.g., for the “N1 hours after breakfast” event as depicted byFIG. 21, which in this case caused the violation. If such a help flag“*” is provided, then a help message 631 is in process step 632. Forexample, the information provided in the help message 631 can beincluded in the helping information 625, and can include, but notlimited thereto, web addresses of online help content, and names andnumbers of social support networks. The patient 12 in still otherembodiments such information may also include suggestions on how to dealwith the situation(s) where an adherence violation had occurred. Forexample, suggestions on what to do when a value of a physiologicalmeasurement collected in response to a collection event is out of theexpected range can be provided. Such suggestions can be provided as alisting of frequently asked questions (FAQ) and answers. Still othersuggestions can ask the patient 12 to make assessments as to whether theviolation is a recurring pattern, or a singular data point attributed toa particular acute issues, such e.g., the patient is on vacation andtherefore explainable, or chronic where nothing has changed, therebypossibly indicating that something physiological or medicinally haschanged, and therefore a change may be needed before continuing.

As discussed in the previous sections provided above, when the patient12 encounters a severe hypoglycemic event, the recommendation providedby the device 24 would be to contact the clinician 14. However, in stillother embodiments, additional guidance can be provided to ensure thatsuch an adverse event does not persist, e.g., eat some carbohydrates,measure again after some time, and the likes.

In one embodiment, after the processor 102 evaluates that the exitcriteria 228 is met in process step 326, in process step 638 theprocessor 102 can provided automatically a status report, such as aresult message 640. The result message 640 in one embodiment can beprovided by the processor 102 on display 108, or communicated to anexternal device 132 via communication interface 124, e.g., in order toprovide the result message 640 to the clinician 14. In anotherembodiment, in process step 638 the processor 102 calculatesautomatically adherence based on the patient data stored in memory 110(i.e., data records 152 stored in data file 145), and providesautomatically the status report based on the calculated adherence. Insuch embodiments, the result message 640 provided by the processor 102can indicate to the patient 12 and/or the clinician 14 the results ofthe structured collection procedure 70, a predication as to what toexpect as a result of performing the structured collection procedure,and/or a prediction based on the calculated overall adherence, e.g.,“Adherence excellent, therapy will be most efficient”, and the like. Instill another embodiment, the processor 102 runs automatically a secondstructured collection procedure (e.g., one or more additional structuredcollection procedures 70 a, 70 b, 70 c, and/or 70 d as discussedpreviously above) upon meeting the exit criteria of the previousstructured collection procedure, and then provides the result message640 when the exit criteria of the second (or last) structured collectionprocedure is met. Again, the result message 640 can be the results ofthe structured collection procedure 70, a predication as to what toexpect as a result of performing the one or more structured collectionprocedures, and/or a prediction based on the calculated overalladherence (i.e., based on the patient data resulting from completing theone or more structured collection procedures), such to, e.g., predicthealth status, weight status, and the likes after completing the last ofthe one or more additional structured collection procedures and whichcan be displayed on the display 108 and/or communicated to an externaldevice 132 by the processor 102. In another embodiment, the resultmessage 640 is automatically sent via communication interface 124 to theclinician 14 indicating that the patient 12 has completed the structuredcollection procedure 70. In still other embodiments, after the processor102 evaluates that the exit criteria 228 is not met in process step 326(FIG. 20), the processor 102 then checks to see in process step 634 if adefined deviation(s) 635 from an expected behavior is occurring in theexecution of the collection procedure 70, and if so, then the device 24can suggest that the patient 12 contacts the clinician 14 via displayinga contact message 633 in process step 636. In the one embodiment, thecontact message 633 can be the same message as the failed message 617,or in another embodiment, it own defined and customizable message in thecollection procedure 70. Also, one example of when a patient's behaviordeviates greatly from what is expected is as follows. When the patient12 undergoes a titration structured collection procedure 70, if theprocessor 102 notes that data values 256 of the measured value for bloodglucose in the data file 145 (FIG. 21) do not show any lowering offasting bG values over a pre-defined period of time in spite ofincreasing dosages of insulin, the contact message 633 will be sent.Other such deviation examples can be pre-defined via logical operations(e.g., Boolean and conditional logic) provided in a deviation parameter635 (FIG. 21) provided in the options of the collection procedure 70 andwhich can be customized by the clinician 14 as desired.

In still other embodiments, the clinician 14 upon receiving the datafile 145 (e.g., during a routine patient visit, routine data collectionfrom the device 24 to the clinician computer 25, at completion of acollection procedure 70, etc.), uses the clinician computer 25 to reviewof a number of quality metrics, such as adherence, acceptance,hypoglycemia, severe hypoglycemia, hyperglycemia, and average glycemiabefore and after the completion of the collection procedure 70.

The clinician 14 can also use data provided in the data file 145 e.g.,collected as part of a routine data collection request from theclinician computer to the device 24 or as part of a scheduled datatransmission of the device 24, to perform a comparison of the progressof their patient relative to a patient group, such as others withintheir practice, or against a general population (such as a manufacturermaintained data store) on the clinician computer. In one embodiment,such comparisons can include the quality metrics mentioned above, timemeasure—alignment of change relative to others in a population, or costmeasures. Such comparisons provide a simple indication to the clinician14 whether the patient 12 is well aligned with others, or in need anintervention in the form of skill education, objective education, orprocedure exclusion. Based on the collected data file 145, if thecollection procedure 70 is still not completed, a report can be run onthe clinician computer 25 which provides a prediction of the estimatedcompletion time of the collection procedure 70 by the patient. Such anestimate can be base on a determination of how well the patient isprogressing in adhering to the collection procedures based on the numberof violation which have occurred. For example, for one collectionprocedure the patient is requested to provide seven days of fastingsamples, of which the last three are utilized by an algorithm to make arecommended dosage change. If the patient fails to provide the lastthree (key) samples, in such an example, the device will not make arecommendation but rather extend automatically the collection procedureby the lost week. In such an example, the estimate would be in anotherweek. In still another example, if a collection procedure requests aclinician intercession whenever a specific collection value exceeds atarget value, the clinician computer 25 could run a prediction algorithmbase on data updates received automatically from the device 24 as towhen the patient will exceed the target value. Based on such anestimate/prediction, the clinician computer 25 can automaticallyidentify the ‘best’ next opportunity for a clinical visit. Additionally,the clinician computer 25 can automatically present context relativequestions or discussion points for the clinical visit based on the time,quality, or cost measures. For example, if, at time of the office visit,the patient data shows that a basal titration is running slower than apopulation of similar individuals (e.g., off a population basedtrajectory), and the patient has not presented a high number ofviolations, then the clinician computer 25 could suggest the clinician14 discuss meal size, type, and timing with the patient. The cliniciancomputer 25 may also suggest that the clinician 14 review what it meansto fast, as well as suggest that the clinician evaluate the efficacy ofthe patient's sampling methodology.

Additional aspects that can be considered are: automatic adjustment ofthe progress indicator from the predicted outcome based on dataprovided; encouragement prompting incorporating either positive items asseen by the system (You are doing an excellent job acquiring yourfasting data. Keep up the good work!), or negative items as seen by thesystem (You have been missing a number of insulin infusions, let's seeif we can do better); education prompting—if the user does notunderstand what they are doing, we can detect this, and ask questionstargeted at assessing their educational needs.

Results at the End of the Structured Collection Procedure

There are a number of different results that can be provided to thepatient 12 at the conclusion of the structured collection procedure 70.Examples are: displaying of the analysis result, e.g. recommendation 260(FIG. 6A); providing a listing of the number e.g., the violation counterand/or which adherence violations 613 occurred for what event 237 duringthe structured collection procedure 70; providing changes in the resulte.g., recommendation 260, when compared to a previous result; providinga status on the patient's long term health condition by comparing datain the data file 145 to known guidelines; providing a comparison of thepatient's long term health condition relative to a population; providinga comparison of previous executions of the structured collectionprocedure 70 versus the current results or results of other types ofstructured collection procedures; and providing a metric showing thenumber of messages successfully delivered divided by the total number ofmessages, e.g., expressed as a percentage. In still other embodiments,other reports may include: provide a cost accounting of the execution ofthe structured collection procedure as an absolute (i.e., a costbased/benefit analysis), as experienced by the patient 12 (minus thatcovered by insurance), compared to others running the same structuredcollection procedure within the clinician 14 population, or against thegeneral population (such as a manufacturer maintained data store).

In still other embodiments, other reports may include: reporting thetime it took to run the structured collection procedure; comparing thetime it took to run the structured collection procedure 70 againstothers within the clinician population, or against a general population(such as a manufacture maintained data store); identifying reasons whythe structured collection procedure took the time that it did (in theevent that the structured collection procedure took longer than optimal)e.g., a listing of the adherence violations (number and type); providingpre-defined questions to establish a rational for the delay, to helpexplain the results (if non-optimal), to educate the patient 12 bytriggering thought provoking educational opportunities, and/or to starta coaching-based dialog between the clinician 14 and patient 12.

It is to be appreciated that the manner in which the results areconveyed can be dependent on the analysis as well. For simplerstructured collection procedures, the results can be displayed directlyon the device 24. However, for analysis routines that are complex,several options exist: the data file 145 is downloaded to cliniciancomputer 25 and the analysis is completed on clinician computer 25wherein the results are discussed in person and stored in the electronicmedical record of the patient 12; the analysis is completed using thepatient computer 18 with included analysis software; or the analysis isprocessed and then made available via a secure web server. Portions onthe data files 145 can also be made available to the developer, forpurposes of analytics, e.g., to determine the percentage ofcompletion/dropouts at various phase of the structured collectionprocedure 70 to help identify possible completion strategies forpatients and providers as well as identifying locations for futureimprovements.

Although not limited thereto, the various status reporting embodimentsof the present invention offer the following advantages. Various ones ofthe status reporting embodiments ensure that the patient 12 has an ideaabout his/her status during collection procedure execution. Providingthis information can lead to an increased adherence and compliance tothe structured collection procedure 70 (i.e., facilitating progressreporting and helping to ensure that minimum collection requirements aresatisfied). Various ones of the status reporting embodiments ensure thatthe patient 12 knows how to address situations where his or her bGvalues are severely out of control, e.g., a status report can beprovided on the device 24 which warns the patient 12 in the case of asevere hypoglycemic event. Other such exception handling type reportscan also be provided. In still other embodiments, the tailored form ofthe status report also ensures that the clinician 14 readily knowsrelevant information about the patient's glycemic state during and atthe end of the structured collection procedure 70. Various ones of thestatus reporting embodiments also allow a structured collectionprocedure 70 report comparison with previous executions of the samestructured collection procedure 70.

Although not limited thereto, the various status reporting embodimentsof the present invention offer the following additional benefits.Various ones of the status reporting embodiments can serve as a means tofoster more focused and pertinent conversations between the clinician 14and the patient 12 regarding the latter's disease status. Various onesof the status reporting embodiments can help to ensure that the initialexperience (e.g., disease state determination) using the collectionprocedure 70 is a positive one, and thus increase the chances that thepatient would perform the same and/or other such structured collectionprocedures again on the device 24.

Thus, by the above disclosure embodiments, various systems and methodsmanaging the execution, data collection, data analysis of collectionprocedures running simultaneously on a meter, and status reporting aredisclosed. One skilled in the art will appreciate that the teachings canbe practiced with embodiments other than those disclosed. The disclosedembodiments are presented for purposes of illustration and notlimitation, and the invention is only limited by the claims that follow.

What is claimed is:
 1. A collection device which performs a structuredcollection procedure which addresses a medical question, said devicecomprising: a display; a memory; a processor connected to the memory andthe display; and program instructions which when executed by theprocessor cause the processor to: initiate a schedule of events of thestructured collection procedure upon one or more entry criteria beingmet, collect patient data for the structured collection procedure whenentered in response to a request in accordance with an event provided inthe schedule of events after initiation, store automatically in thememory the collected patient data, assess automatically whether thecollected patient data in response to the request meets one or moreadherence and/or acceptance criteria, wherein the one or more adherenceand/or acceptance criteria is a different criteria from the entrycriteria, wherein the one or more adherence and/or acceptance criteriacomprises a defined range of values, and if the patient data does notfall within the range, the processor is configured to prompt foradditional patient data and automatically extend the events in theschedule of events if an assessment provided by the processor is thatsteps leading up to taking of the patient data were not accomplished;associate automatically with the stored collected patient data a uniqueidentifier in the memory if satisfying the one or more adherence and/oracceptance criteria, provide automatically a status report when the oneor more adherence and/or acceptance criteria are not met during thestructured collection procedure, and end automatically the structuredcollection procedure upon one or more exit criteria being met, whereinthe exit criteria establishes requirements which need to be met forexiting or completing the structured collection procedure such thatadequate contextual data is collected to answer the medical questionaddressed by the structured collection procedure and wherein theschedule of events of the structured collection procedure continues ontoa next event by which to collect further patient data until therequirements for the exit criteria are met; wherein when executed by theprocessor, the program instructions further cause the processor to:check whether the patient data collected in response to the requestwhich do not meet the one or more adherence criteria causes an adherenceviolation, to count the number of adherence violations, and endautomatically the structured collection procedure when the number ofadherence violations exceeds an acceptable number of adherenceviolations for a particular type of violation, wherein the type ofviolation is indicated by the processor, which is configured to providetype codes for what caused the violation, and the processor isconfigured to provide the type codes of: a measurement taken before awindow, the measurement taken after the window, the measurement skipped,incorrect amount of a medication taken, the medication is not taken, andthe medication is taken at an incorrect time; and wherein the processorsets, for each type code, the number of adherence violations for theautomatic ending of the procedure.
 2. A collection device according toclaim 1 further comprising a communication interface and wherein theprogram instructions, which when executed by the processor, furthercause the processor to send a message via the communication interface toa clinician if the adherence and/or acceptance criteria are not met. 3.A collection device according to claim 1 wherein when the one or moreadherence and/or acceptance criteria are not met during the structuredcollection procedure the program instructions further cause theprocessor to present on the display questions and answers to determinewhy the adherence and/or acceptance criteria were not met.
 4. Acollection device according to claim 1 wherein the program instructions,which when executed by the processor, further cause the processor todisplay a message on the display to contact a clinician if the adherencecriteria are met but not the acceptance criteria.
 5. A collection deviceaccording to claim 1 wherein when the one or more adherence criteria arenot met during the structured collection procedure the programinstructions further cause the processor to present on the display aprediction as to what is likely to happen if the patient continues notto meet the one or more adherence criteria.
 6. A collection deviceaccording to claim 1 wherein the processor provides a status indicatoron the display showing progress of completing the structured collectionprocedure.
 7. A collection device according to claim 6 wherein progressof the status indicator is based in part on the number of uniqueidentifiers associated with the stored collected patient data.
 8. Acollection device according to claim 6 wherein progress of the statusindicator is based on the number of unique identifiers associated withthe stored collected patient data and a total number of the requests inthe schedule of events which need to meet the one or more adherencecriteria in order for the one or more exit criteria to be met at someunknown time.
 9. A collection device according to claim 6 whereinprogress of the status indicator is based the number of uniqueidentifiers associated with the stored collected patient data divided bya total number of the requests in the schedule of events which need tomeet the one or more adherence criteria in order for the one or moreexit criteria to be met at some unknown time, and provided on thedisplay as either a fraction or as a percentage.
 10. A collection deviceaccording to claim 6 wherein the status indicator represents one of agas gage and a progress bar.
 11. A collection device according to claim1 wherein the program instructions, which when executed by theprocessor, further cause the processor to provide a failure message onthe display and end automatically the structured collection procedurewhen the number of adherence violations exceeds an acceptable number ofadherence violations.
 12. A collection device according to claim 1wherein the program instructions, which when executed by the processor,further cause the processor to check whether the number of adherenceviolations exceeds an acceptable number of adherence violations.
 13. Acollection device according to claim 12 wherein the programinstructions, which when executed by the processor, further cause theprocessor to provide a triage message that indicates a risk of notcompleting the structured collection procedure if the number ofadherence violations has not exceeded the acceptable number of adherenceviolations.
 14. A collection device according to claim 12 wherein theprogram instructions, which when executed by the processor, furthercause the processor to provide on the display a help message if thenumber of adherence violations has not exceeded the acceptable number ofadherence violations, and if a designation has been made in thestructured collection procedure, to provide the help message for theevent.
 15. A collection device according to claim 12 wherein the programinstructions, which when executed by the processor, further cause theprocessor to provide on the display a query message designated in thestructured collection procedure if the number of adherence violationshas not exceeded the acceptable number of adherence violations, and if adesignation has been made in the structured collection procedure, toprovide the query message for the event.
 16. A collection deviceaccording to claim 15 wherein the program instructions, which whenexecuted by the processor, further cause the processor to provide on thedisplay helping information designated in the structured collectionprocedure if a response received by the processor to the query messageis a request for the helping information.
 17. A collection deviceaccording to claim 16 wherein the program instructions, which whenexecuted by the processor further cause the processor to provide on thedisplay a second query message designated in the structured collectionprocedure after providing the helping information.
 18. A collectiondevice according to claim 17 wherein the program instructions, whichwhen executed by the processor further cause the processor to send amessage to a clinician if a response received by the processor to thesecond query message is to send the message to the clinician.
 19. Acollection device according to claim 1 wherein the program instructions,which when executed by the processor further cause the processor tocheck whether the collected patient data in memory is deviating from anexpected behavior.
 20. A collection device according to claim 19 whereinthe program instructions, which when executed by the processor, furthercause the processor to provide on the display a contact messagedesignated in the structured collection procedure if the collectedpatient data in memory is deviating from the expected behavior.
 21. Acollection device according to claim 1 wherein the program instructions,which when executed by the processor, further cause the processor toprovide on the display starting information before the one or more entrycriteria is met at some unknown time, wherein the starting informationprovides at least the purpose of the structured collection procedure andthe conditions needed to meet the one or more entry criteria.
 22. Acollection device according to claim 1 wherein the program instructions,which when executed by the processor, further cause the processor toprovide on the display a selectable report, which when selected,displays current status information of the structured collectionprocedure.
 23. A collection device according to claim 22 wherein thecurrent status information comprises one or more of the following piecesof information regarding the structured collection procedure: progressof completion, outcome of the collection procedure, number ofviolations, type of violation, events completed, events left tocomplete, cost based analysis, and a comparison of previous executionsof the structured collection procedure with current results or resultsof other types of structured collection procedures.
 24. A collectiondevice according to claim 1, wherein the status report is provided bythe processor, if for the event in which the one or more adherencecriteria is not met during the structured collection procedure, aviolation is designated in the collection procedure by a selectableviolation parameter provided in the structured collection procedure. 25.A collection device according to claim 1, wherein the processor endsautomatically the structured collection procedure when the number ofadherence violations exceeds the acceptable number of adherenceviolations in a predefined period of time.
 26. The collection device ofclaim 1 wherein the one or more adherence and/or acceptance criteriacomprises two or more criteria comprising the defined range of valuesand a predetermined value, and wherein the patient data comprises anaverage value used to determine a percentage of adherence.
 27. Thecollection device of claim 1 wherein the memory is configured to storean email address or internet protocol (IP) address of a physician, andthe processor is configured to automatically send messages to thephysician, the messages comprising: that the patient has started thestructured collection procedure via satisfying the entry criteria, thatthe patient has failed one of the events by not satisfying the one ormore adherence criteria, and that the patient has completed thestructured collection procedure when the exit criteria is satisfied; andwherein the display is configured to expose the patient to a partialreporting of on-going results in anticipation of a reporting the patientwill receive via the display upon completion of the structuredcollection procedure.
 28. A collection device which performs astructured collection procedure which addresses a medical question, saiddevice comprising: a display; a memory; a processor connected to thememory and the display; and program instructions which when executed bythe processor cause the processor to: initiate a schedule of events ofthe structured collection procedure upon one or more entry criteriabeing met, collect patient data for the structured collection procedurewhen entered in response to a request in accordance with an eventprovided in the schedule of events after initiation, store automaticallyin the memory the collected patient data, assess automatically whetherthe collected patient data in response to the request meets one or moreadherence and/or acceptance criteria, wherein the one or more adherenceand/or acceptance criteria is a different criteria from the entrycriteria, wherein the one or more adherence and/or acceptance criteriacomprises a defined range of values, and if the patient data does notfall within the range, the processor is configured to prompt foradditional patient data and automatically extend the events in theschedule of events if an assessment provided by the processor is thatsteps leading up to taking of the patient data were not accomplished;associate automatically with the stored collected patient data a uniqueidentifier in the memory if satisfying the one or more adherence and/oracceptance criteria end automatically the structured collectionprocedure upon one or more exit criteria being met, wherein the exitcriteria establishes requirements which need to be met for exiting orcompleting the structured collection procedure such that adequatecontextual data is collected to answer the medical question addressed bythe structured collection procedure and wherein the schedule of eventsof the structured collection procedure continues onto a next event bywhich to collect further patient data until the requirements for theexit criteria are met, calculate overall adherence based on the patientdata stored in memory, and provide automatically a status report basedon the calculated adherence, wherein the status report is one of aprediction displayed on the display by the processor and a statusmessage sent automatically to a clinician; and wherein when executed bythe processor, the program instructions further cause the processor to:check whether the patient data collected in response to the requestwhich do not meet the one or more adherence criteria causes an adherenceviolation, to count the number of adherence violations, and endautomatically the structured collection procedure when the number ofadherence violations exceeds an acceptable number of adherenceviolations for a particular type of violation, wherein the type ofviolation is indicated by the processor, which is configured to providetype codes for what caused the violation, and the processor isconfigured to provide the type codes of: a measurement taken before awindow, the measurement taken after the window, the measurement skipped,incorrect amount of a medication taken, the medication is not taken, andthe medication is taken at an incorrect time; and wherein the processorsets, for each type code, the number of adherence violations for theautomatic ending of the procedure.
 29. A collection device according toclaim 28 wherein the program instructions, which when executed by theprocessor, further cause the processor to run automatically one or moreadditional structured collection procedures after the one or more exitcriteria is met, and to calculate the overall adherence based on thepatient data stored in memory when exit criteria of the last of the oneor more additional structured collection procedures is met.
 30. Acollection device according to claim 29 wherein the status report is oneof a prediction displayed on the display by the processor and a statusmessage sent automatically to a clinician.
 31. A method of performing astructured collection procedure which addresses a medical question,comprising: providing a collection device which comprises a display, amemory, a processor connected to the memory and the display, and programinstructions which when executed by the processor cause the processorto: initiate a schedule of events of the structured collection procedureupon one or more entry criteria being met, collect patient data for thestructured collection procedure when entered in response to a request inaccordance with an event provided in the schedule of events afterinitiation, store automatically in the memory the collected patientdata, assess automatically whether the collected patient data inresponse to the request meets one or more adherence and/or acceptancecriteria, wherein the one or more adherence and/or acceptance criteriais a different criteria from the entry criteria, wherein the one or moreadherence and/or acceptance criteria comprises a defined range ofvalues, and if the patient data does not fall within the range, theprocessor is configured to prompt for additional patient data andautomatically extend the events in the schedule of events if anassessment provided by the processor is that steps leading up to takingof the patient data were not accomplished, associate automatically withthe stored collected patient data a unique identifier in the memory ifsatisfying the one or more adherence and/or acceptance criteria, provideautomatically a status report when the one or more adherence and/oracceptance criteria are not met during the structured collectionprocedure, and end automatically the structured collection procedureupon one or more exit criteria being met, wherein the exit criteriaestablishes requirements which need to be met for exiting or completingthe structured collection procedure such that adequate contextual datais collected to answer the medical question addressed by the structuredcollection procedure and wherein the schedule of events of thestructured collection procedure continues onto a next event by which tocollect further patient data until the requirements for the exitcriteria are met; wherein when executed by the processor, the programinstructions further cause the processor to: check whether the patientdata collected in response to the request which do not meet the one ormore adherence criteria causes an adherence violation, to count thenumber of adherence violations, and end automatically the structuredcollection procedure when the number of adherence violations exceeds anacceptable number of adherence violations for a particular type ofviolation, wherein the type of violation is indicated by the processor,which is configured to provide type codes for what caused the violation,and the processor is configured to provide the type codes of: ameasurement taken before a window, the measurement taken after thewindow, the measurement skipped, incorrect amount of a medication taken,the medication is not taken, and the medication is taken at an incorrecttime; and wherein the processor sets, for each type code, the number ofadherence violations for the automatic ending of the procedure; andinitiating the structured collection procedure on the collection device.